--- title: "Architecting Atlassian for Healthcare and FDA Compliance: Part 1" description: Bridging the gap between agile development for innovation and audit readiness for compliance! image: https://blog.scalehealth.com/hubfs/Hero-061.png --- [![Sierra Labs](https://blog.scalehealth.com/hubfs/Sierralabs_January2019%20Theme/Images/sierra-labs-logo.png)](https://www.sierralabs.com/) - Products - [Sierra Policies & Procedures](https://www.sierralabs.com/policies-procedures) - [Sierra Document Automation](https://www.sierralabs.com/document-automation) - [Sierra Quality Management](https://www.sierralabs.com/quality-management) - [Sierra GxP Cloud Validation](https://www.sierralabs.com/cloud-validation) - [Services](https://www.sierralabs.com/services) - [About Us](https://www.sierralabs.com/about) - [Partner](https://campaign.sierralabs.com/partner-with-sierra-labs) - [Blog](https://blog.scalehealth.com) - [Contact Us](https://www.sierralabs.com/document-automation/#contact-us) [Contact Us](https://www.sierralabs.com/document-automation/#contact-us)   ## Sierra Labs Blog This is a search field with an auto-suggest feature attached. - There are no suggestions because the search field is empty. # Architecting Atlassian for Healthcare and FDA Compliance: Part 1 Posted by [Sierra Labs](https://blog.scalehealth.com/author/sierra-labs) on Jan 15, 2022, 12:23:48 PM - [Tweet](https://twitter.com/share) Bridging the gap between agile development for innovation and audit readiness for compliance! ![Hero-061](https://blog.scalehealth.com/hs-fs/hubfs/Hero-061.png?width=6400&name=Hero-061.png) The regulatory landscape for Medical Devices, Biotech, Pharma, and Healthcare is constantly changing and adapting to the new technologies of today. Despite these changes, the goal for regulatory bodies like the FDA remains the same -- to protect patients' safety and privacy. Is there a way for Healthcare and Life Science companies to use the agile methodology that goes hand in hand with technological advancements while still maintaining compliance to FDA's rigid regulation framework? Absolutely.  To accomplish this feat, there is a definite need across the industry for a more synchronized quality system for custom documents and workflows that abides by FDA regulations and that can help prepare for submissions, certifications, and audits. Our compliance experts have developed a guide to address the gap found in companies that look to operate with agile processes while maintaining strict FDA compliance throughout the entirety of their [regulatory roadmap](https://blog.scalehealth.com/6-regulatory-pathways-to-bring-your-medical-device-to-market). **A New Way of Managing Data** In this day and age, information is in a constant cycle of updates. Thus, there is an inherent need to revolutionize the way we, companies serving the Healthcare industry, manage sensitive data and workflows. You want to avoid the FDA deeming your company's processes unsafe simply because your organization failed to integrate audit-ready documentation for your development processes. But how do you increase visibility while not running into compliance issues? Who has access to a valuable piece of information or who can even sign off on a crucial document? This is where a Quality Management System (QMS) with role-based permissions and automated document exporting comes into play. **Staying Ahead of the Curve** You might have already heard of “[ISO 13485](https://blog.scalehealth.com/iso-13485-regulatory-requirements-on-medical-devices)” or even "[21 CFR Part 11](https://blog.scalehealth.com/5-ways-to-stay-compliant-with-fda-21-cfr-part-11)" in your prior research regarding compliance for your device; these are concepts that are often foreign when looking into an eQMS for your organization. [Learn the right steps to adopting an eQMS for your Medical Device or Life Science organization.](https://blog.scalehealth.com/6-steps-to-implementing-a-qms-software-for-life-sciences) It is a good start to discuss these concepts with your team ahead of the development process to compile a more precise regulatory roadmap. Development is often pushed back due to teams overlooking regulatory requirements or certification processes while managing and assessing risks and reviews for their device. Luckily for you, there is an integration that can take care of most of those processes for you and reduce manual overhead, but first, you must analyze your current organization’s quality processes. **Quick Overview of Agile and Waterfall** [Agile project management](https://blog.scalehealth.com/fda-and-agile-qms-for-samd) is an iterative approach to delivering a project, which focuses on continuous releases that incorporate customer feedback. The ability to adjust during each iteration promotes velocity and adaptability. This approach contrasts a linear, waterfall project management approach, which instead follows a set/structured path with limited deviation. Your team might be using a hybrid model of agile and waterfall processes to help reduce the cost of development while driving continuous improvements to the overall quality of the final product. Despite the model your organization currently operates in, a lot of teams developing solutions for the Healthcare industry are still choosing smart tools to automate certain components of their workflows. Components like documentation and collaboration are crucial for teams who operate in highly accelerated environments and use agile methodology. **How Atlassian's Jira Integration Bridges the Gap** Current startups and mid-sized companies in the Medical Devices, Biotech, Pharma, and Healthcare spaces face problems with: - Lack of integrations - Poor usability in design - Impractical exportability An electronic Quality Management System (eQMS) can expedite processes like document upload and data traceability, but as far as capturing snapshots on the current flow of work, [Atlassian Jira integration](https://blog.scalehealth.com/what-atlassians-elimination-of-jira-server-means-for-your-business) is ideal for these scenarios where your team relies on optimal sprint management. The Sierra Labs compliance team has compiled key features that would benefit your team when adopting an eQMS that integrates with Jira: | **Features** | **Description** | | --- | --- | | Electronic Signature | Manage approvals of all items and deliverables through a unique ID with a date and time stamp that is compliant with 21 CFR Part 11. | | Audit-ready Log | Compile an archive of all identification codes that pertain to approvals and reviews with the click of a button. | | Publisher | Import templates from word or other document publishing tools and export data into a document management system (DMS). | | Testing add-ons | Repurpose test libraries over time as you continue to iterate on these releases. | | [CAPA](https://blog.scalehealth.com/what-are-capas-for-fda-iso-) | Manage CAPAs through various docs and templates within your Jira environment. | | Status | Notify your team of status and change of status for various workflows at a time. | | Script | Enforce policies and Standard Operating Procedures (SOPs) to your team seamlessly. | | Mobile Tracking | Track alerts and important notifications while remote or on the road through the mobile application. |   **A QMS that Integrates with Atlassian's Jira** If you’re developing a solution in the Healthcare or Life Science space where you must show high levels of traceability, a Quality Management Systems (QMS) is a crucial part of your regulatory compliance. Our solutions smoothly integrate with Atlassian Jira Server and Cloud products, making it easier for our clients to implement a QMS that is compliant with FDA's regulatory framework, 21 CFR Part 820 and 21 CFR Part 11. [Sierra QMS](https://www.sierralabs.com/quality-management/) helps medical device, biotech, pharmaceutical, and clinical research companies to reduce their regulatory compliance burden by providing them with customized software solutions that integrate with Atlassian Jira and Confluence. These software products enable companies of any life-cycle stage to streamline regulatory documents and quality management processes. Sierra Labs is focused on aligning engineering/IT teams with quality and compliance teams in FDA-regulated environments. Our automated eQMS, cloud validation system, and other agile tools are designed to be easily adaptable in pre-existing workflows and assist teams in producing validation and verification artifacts needed in high-quality environments. **Want to see how implementing Sierra QMS can accelerate your journey to market?** **Click Here for a Free Demo!** **[![Free QMS Demo](https://hubspot-no-cache-na2-prod.s3.amazonaws.com/cta/default/5229980/f27812b5-b886-4f1d-8e72-5aef5daeb957.png)](https://hubspot-cta-redirect-na2-prod.s3.amazonaws.com/cta/redirect/5229980/f27812b5-b886-4f1d-8e72-5aef5daeb957)** It's that simple. Check out our compliance leader’s full Atlassian presentation on this subject:   Topics: [FDA](https://blog.scalehealth.com/tag/fda), [QMS](https://blog.scalehealth.com/tag/qms), [Medical Device](https://blog.scalehealth.com/tag/medical-device), [Medical Device Company](https://blog.scalehealth.com/tag/medical-device-company), [Regulatory Pathway](https://blog.scalehealth.com/tag/regulatory-pathway), [Regulatory Strategy](https://blog.scalehealth.com/tag/regulatory-strategy), [Quality System Regulation](https://blog.scalehealth.com/tag/quality-system-regulation), [SaMD QMS](https://blog.scalehealth.com/tag/samd-qms), [Life Science QMS](https://blog.scalehealth.com/tag/life-science-qms), [QMS healthcare](https://blog.scalehealth.com/tag/qms-healthcare) ## Featured posts ### Topics - [FDA (42)](https://blog.scalehealth.com/tag/fda) - [QMS (31)](https://blog.scalehealth.com/tag/qms) - [Compliance (28)](https://blog.scalehealth.com/tag/compliance) - [Medical Device (27)](https://blog.scalehealth.com/tag/medical-device) - [Medical Device Company (26)](https://blog.scalehealth.com/tag/medical-device-company) - [SaMD (26)](https://blog.scalehealth.com/tag/samd) - [Data Security (17)](https://blog.scalehealth.com/tag/data-security) - [Regulations (17)](https://blog.scalehealth.com/tag/regulations) - [21 CFR Part 820 (15)](https://blog.scalehealth.com/tag/21-cfr-part-820) - [Medical Devices (15)](https://blog.scalehealth.com/tag/medical-devices) - [ISO (14)](https://blog.scalehealth.com/tag/iso) - [FDA Approval (13)](https://blog.scalehealth.com/tag/fda-approval) - [Agile (12)](https://blog.scalehealth.com/tag/agile) - [Data Privacy (12)](https://blog.scalehealth.com/tag/data-privacy) - [FDA Regulation (12)](https://blog.scalehealth.com/tag/fda-regulation) - [ISO 13485 (11)](https://blog.scalehealth.com/tag/iso-13485) - [SaMD Development (11)](https://blog.scalehealth.com/tag/samd-development) - [CFR Part 820 (10)](https://blog.scalehealth.com/tag/cfr-part-820) - [Data Requirements (10)](https://blog.scalehealth.com/tag/data-requirements) - [Document Controls (10)](https://blog.scalehealth.com/tag/document-controls) - [FDA Pre-Sub (10)](https://blog.scalehealth.com/tag/fda-pre-sub) - [Health Technology (10)](https://blog.scalehealth.com/tag/health-technology) - [Regulatory Pathway (10)](https://blog.scalehealth.com/tag/regulatory-pathway) - [AI (9)](https://blog.scalehealth.com/tag/ai) - [Documentation (9)](https://blog.scalehealth.com/tag/documentation) - [GxP Cloud (9)](https://blog.scalehealth.com/tag/gxp-cloud) - [Quality System Regulation (9)](https://blog.scalehealth.com/tag/quality-system-regulation) - [Technology (9)](https://blog.scalehealth.com/tag/technology) - [Validated Cloud (9)](https://blog.scalehealth.com/tag/validated-cloud) - [risk (9)](https://blog.scalehealth.com/tag/risk) - [Cloud (8)](https://blog.scalehealth.com/tag/cloud) - [FDA Audit (8)](https://blog.scalehealth.com/tag/fda-audit) - [GxP (8)](https://blog.scalehealth.com/tag/gxp) - [Health Data (8)](https://blog.scalehealth.com/tag/health-data) - [ISO 13485:2016 (8)](https://blog.scalehealth.com/tag/iso-134852016) - [ISO 14971 (8)](https://blog.scalehealth.com/tag/iso-14971) - [Manufacturing (8)](https://blog.scalehealth.com/tag/manufacturing) - [PHI (8)](https://blog.scalehealth.com/tag/phi) - [Personal Health Information (8)](https://blog.scalehealth.com/tag/personal-health-information) - [Conformity (7)](https://blog.scalehealth.com/tag/conformity) - [Healthcare (7)](https://blog.scalehealth.com/tag/healthcare) - [Life Science QMS (7)](https://blog.scalehealth.com/tag/life-science-qms) - [Medical Solutions (7)](https://blog.scalehealth.com/tag/medical-solutions) - [Product Development (7)](https://blog.scalehealth.com/tag/product-development) - [Regulatory Strategy (7)](https://blog.scalehealth.com/tag/regulatory-strategy) - [SaMD QMS (7)](https://blog.scalehealth.com/tag/samd-qms) - [Software Requirement Specification (7)](https://blog.scalehealth.com/tag/software-requirement-specification) - [Standards (7)](https://blog.scalehealth.com/tag/standards) - [21 CFR (6)](https://blog.scalehealth.com/tag/21-cfr) - [Quality Management System (6)](https://blog.scalehealth.com/tag/quality-management-system) - [Quality Processes (6)](https://blog.scalehealth.com/tag/quality-processes) - [Regulatory Roadmap (6)](https://blog.scalehealth.com/tag/regulatory-roadmap) - [eHealth (6)](https://blog.scalehealth.com/tag/ehealth) - [21 CFR Part 11 (5)](https://blog.scalehealth.com/tag/21-cfr-part-11) - [Artificial Intelligence (5)](https://blog.scalehealth.com/tag/artificial-intelligence) - [CAPA (5)](https://blog.scalehealth.com/tag/capa) - [COVID19 (5)](https://blog.scalehealth.com/tag/covid19) - [Design Controls (5)](https://blog.scalehealth.com/tag/design-controls) - [Digital Health (5)](https://blog.scalehealth.com/tag/digital-health) - [Health Tech (5)](https://blog.scalehealth.com/tag/health-tech) - [Jira Cloud (5)](https://blog.scalehealth.com/tag/jira-cloud) - [Jira QMS (5)](https://blog.scalehealth.com/tag/jira-qms) - [New Drugs (5)](https://blog.scalehealth.com/tag/new-drugs) - [QMS healthcare (5)](https://blog.scalehealth.com/tag/qms-healthcare) - [Sierra QMS (5)](https://blog.scalehealth.com/tag/sierra-qms) - [training management (5)](https://blog.scalehealth.com/tag/training-management) - [Automation (4)](https://blog.scalehealth.com/tag/automation) - [Biopharma (4)](https://blog.scalehealth.com/tag/biopharma) - [Business Associates (4)](https://blog.scalehealth.com/tag/business-associates) - [Communication (4)](https://blog.scalehealth.com/tag/communication) - [Covered Entities (4)](https://blog.scalehealth.com/tag/covered-entities) - [Data Integrity (4)](https://blog.scalehealth.com/tag/data-integrity) - [Development Change (4)](https://blog.scalehealth.com/tag/development-change) - [Drug Approval (4)](https://blog.scalehealth.com/tag/drug-approval) - [GAMP5 (4)](https://blog.scalehealth.com/tag/gamp5) - [HIPAA (4)](https://blog.scalehealth.com/tag/hipaa) - [HIPAA Compliance (4)](https://blog.scalehealth.com/tag/hipaa-compliance) - [Health Applications (4)](https://blog.scalehealth.com/tag/health-applications) - [Integrated QMS (4)](https://blog.scalehealth.com/tag/integrated-qms) - [Medical Device Startups (4)](https://blog.scalehealth.com/tag/medical-device-startups) - [Pre-Submission (4)](https://blog.scalehealth.com/tag/pre-submission) - [Product Lifecycle (4)](https://blog.scalehealth.com/tag/product-lifecycle) - [Quality Roadmap (4)](https://blog.scalehealth.com/tag/quality-roadmap) - [Recall (4)](https://blog.scalehealth.com/tag/recall) - [Regulatory Approach (4)](https://blog.scalehealth.com/tag/regulatory-approach) - [Remote Work (4)](https://blog.scalehealth.com/tag/remote-work) - [Scale-ups (4)](https://blog.scalehealth.com/tag/scale-ups) - [Software (4)](https://blog.scalehealth.com/tag/software) - [Streamline Workflows (4)](https://blog.scalehealth.com/tag/streamline-workflows) - [document management (4)](https://blog.scalehealth.com/tag/document-management) - [ePHI (4)](https://blog.scalehealth.com/tag/ephi) - [510(k) (3)](https://blog.scalehealth.com/tag/510k) - [COVID-19 Solution (3)](https://blog.scalehealth.com/tag/covid-19-solution) - [Case Study (3)](https://blog.scalehealth.com/tag/case-study) - [Compliance Process (3)](https://blog.scalehealth.com/tag/compliance-process) - [Cybersecurity (3)](https://blog.scalehealth.com/tag/cybersecurity) - [DTx (3)](https://blog.scalehealth.com/tag/dtx) - [Design Verification (3)](https://blog.scalehealth.com/tag/design-verification) - [Document Automation Tools (3)](https://blog.scalehealth.com/tag/document-automation-tools) - [FDA Standard (3)](https://blog.scalehealth.com/tag/fda-standard) - [GAMP (3)](https://blog.scalehealth.com/tag/gamp) - [HIPAA Checklist (3)](https://blog.scalehealth.com/tag/hipaa-checklist) - [Hardware-based (3)](https://blog.scalehealth.com/tag/hardware-based) - [IEC 62304 (3)](https://blog.scalehealth.com/tag/iec-62304) - [ISPE (3)](https://blog.scalehealth.com/tag/ispe) - [Iterative Process (3)](https://blog.scalehealth.com/tag/iterative-process) - [Life Science (3)](https://blog.scalehealth.com/tag/life-science) - [Medical Technology (3)](https://blog.scalehealth.com/tag/medical-technology) - [Pharma (3)](https://blog.scalehealth.com/tag/pharma) - [Predicate Device (3)](https://blog.scalehealth.com/tag/predicate-device) - [Product Requirements Document (3)](https://blog.scalehealth.com/tag/product-requirements-document) - [QMS for SaMD Startups (3)](https://blog.scalehealth.com/tag/qms-for-samd-startups) - [Risk Management (3)](https://blog.scalehealth.com/tag/risk-management) - [SOC (3)](https://blog.scalehealth.com/tag/soc) - [SOC 2 (3)](https://blog.scalehealth.com/tag/soc-2) - [SOP (3)](https://blog.scalehealth.com/tag/sop) - [SaMD Startups (3)](https://blog.scalehealth.com/tag/samd-startups) - [Software Development (3)](https://blog.scalehealth.com/tag/software-development) - [Telecare (3)](https://blog.scalehealth.com/tag/telecare) - [Telehealth (3)](https://blog.scalehealth.com/tag/telehealth) - [eQMS (3)](https://blog.scalehealth.com/tag/eqms) - [AWS (2)](https://blog.scalehealth.com/tag/aws) - [Audit Trails (2)](https://blog.scalehealth.com/tag/audit-trails) - [CDER (2)](https://blog.scalehealth.com/tag/cder) - [CE Marking (2)](https://blog.scalehealth.com/tag/ce-marking) - [CFR (2)](https://blog.scalehealth.com/tag/cfr) - [Center for Biologics Evaluation and Research (2)](https://blog.scalehealth.com/tag/center-for-biologics-evaluation-and-research) - [Center for Drug Evaluation and Research (2)](https://blog.scalehealth.com/tag/center-for-drug-evaluation-and-research) - [Clinical Evaluation (2)](https://blog.scalehealth.com/tag/clinical-evaluation) - [Corrective Action Preventive Action (2)](https://blog.scalehealth.com/tag/corrective-action-preventive-action) - [Document Automation (2)](https://blog.scalehealth.com/tag/document-automation) - [Document Control (2)](https://blog.scalehealth.com/tag/document-control) - [Documentation Automation (2)](https://blog.scalehealth.com/tag/documentation-automation) - [Electronic Records (2)](https://blog.scalehealth.com/tag/electronic-records) - [GMP (2)](https://blog.scalehealth.com/tag/gmp) - [General Controls (2)](https://blog.scalehealth.com/tag/general-controls) - [HITRUST (2)](https://blog.scalehealth.com/tag/hitrust) - [HITRUST CSF (2)](https://blog.scalehealth.com/tag/hitrust-csf) - [ML (2)](https://blog.scalehealth.com/tag/ml) - [Machine Learning (2)](https://blog.scalehealth.com/tag/machine-learning) - [New Draft (2)](https://blog.scalehealth.com/tag/new-draft) - [Pharmaceutical (2)](https://blog.scalehealth.com/tag/pharmaceutical) - [Pre-market approval (2)](https://blog.scalehealth.com/tag/pre-market-approval) - [QS (2)](https://blog.scalehealth.com/tag/qs) - [Risk Classification (2)](https://blog.scalehealth.com/tag/risk-classification) - [Risk Managment (2)](https://blog.scalehealth.com/tag/risk-managment) - [Sierra Policies (2)](https://blog.scalehealth.com/tag/sierra-policies) - [Sierra Services (2)](https://blog.scalehealth.com/tag/sierra-services) - [Standard Operating Procedure (2)](https://blog.scalehealth.com/tag/standard-operating-procedure) - [fda submission (2)](https://blog.scalehealth.com/tag/fda-submission) - [mHealth Wearables (2)](https://blog.scalehealth.com/tag/mhealth-wearables) - [rta (2)](https://blog.scalehealth.com/tag/rta) - [software as medical device (2)](https://blog.scalehealth.com/tag/software-as-medical-device) - [21 cfr 807 (1)](https://blog.scalehealth.com/tag/21-cfr-807) - [513G (1)](https://blog.scalehealth.com/tag/513g) - [AAMI TIR45 (1)](https://blog.scalehealth.com/tag/aami-tir45) - [AICPA (1)](https://blog.scalehealth.com/tag/aicpa) - [ANVISA (1)](https://blog.scalehealth.com/tag/anvisa) - [Agência Nacional de Vigilância Sanitária (1)](https://blog.scalehealth.com/tag/agência-nacional-de-vigilância-sanitária) - [Amazon Web Services (1)](https://blog.scalehealth.com/tag/amazon-web-services) - [Analytical Validation (1)](https://blog.scalehealth.com/tag/analytical-validation) - [Annex 11 (1)](https://blog.scalehealth.com/tag/annex-11) - [Australian Therapeutic Goods Administration (1)](https://blog.scalehealth.com/tag/australian-therapeutic-goods-administration) - [BLA (1)](https://blog.scalehealth.com/tag/bla) - [Backlog (1)](https://blog.scalehealth.com/tag/backlog) - [Biologic Approval (1)](https://blog.scalehealth.com/tag/biologic-approval) - [Business Goals (1)](https://blog.scalehealth.com/tag/business-goals) - [CGMP (1)](https://blog.scalehealth.com/tag/cgmp) - [Cannabis (1)](https://blog.scalehealth.com/tag/cannabis) - [Cannabis Compliance (1)](https://blog.scalehealth.com/tag/cannabis-compliance) - [Change Control (1)](https://blog.scalehealth.com/tag/change-control) - [Client Reference (1)](https://blog.scalehealth.com/tag/client-reference) - [Clinical Development (1)](https://blog.scalehealth.com/tag/clinical-development) - [Clinical Validation (1)](https://blog.scalehealth.com/tag/clinical-validation) - [Code Reviews (1)](https://blog.scalehealth.com/tag/code-reviews) - [Conference (1)](https://blog.scalehealth.com/tag/conference) - [Coronavirus (1)](https://blog.scalehealth.com/tag/coronavirus) - [Current Good Manufacturing Practice (1)](https://blog.scalehealth.com/tag/current-good-manufacturing-practice) - [Customer Complaint (1)](https://blog.scalehealth.com/tag/customer-complaint) - [Data Transfer (1)](https://blog.scalehealth.com/tag/data-transfer) - [Design Changes (1)](https://blog.scalehealth.com/tag/design-changes) - [Design History File (1)](https://blog.scalehealth.com/tag/design-history-file) - [Design Transfer (1)](https://blog.scalehealth.com/tag/design-transfer) - [Development Team (1)](https://blog.scalehealth.com/tag/development-team) - [Device Classification (1)](https://blog.scalehealth.com/tag/device-classification) - [Device Software Functions (1)](https://blog.scalehealth.com/tag/device-software-functions) - [Document Publishing (1)](https://blog.scalehealth.com/tag/document-publishing) - [Drug Manufacturing (1)](https://blog.scalehealth.com/tag/drug-manufacturing) - [EUA (1)](https://blog.scalehealth.com/tag/eua) - [Electronic Signatures (1)](https://blog.scalehealth.com/tag/electronic-signatures) - [Emergency Use Authorization (1)](https://blog.scalehealth.com/tag/emergency-use-authorization) - [Enforcement Discretion (1)](https://blog.scalehealth.com/tag/enforcement-discretion) - [Engineering (1)](https://blog.scalehealth.com/tag/engineering) - [Ethos Automated System (1)](https://blog.scalehealth.com/tag/ethos-automated-system) - [FDA Draft (1)](https://blog.scalehealth.com/tag/fda-draft) - [HHS (1)](https://blog.scalehealth.com/tag/hhs) - [Hand Sanitizer (1)](https://blog.scalehealth.com/tag/hand-sanitizer) - [Hardware Development (1)](https://blog.scalehealth.com/tag/hardware-development) - [IEC (1)](https://blog.scalehealth.com/tag/iec) - [IEC 60601 (1)](https://blog.scalehealth.com/tag/iec-60601) - [IEC 60601:1 (1)](https://blog.scalehealth.com/tag/iec-606011) - [IEC 62366  (1)](https://blog.scalehealth.com/tag/iec-62366) - [IFU (1)](https://blog.scalehealth.com/tag/ifu) - [IND (1)](https://blog.scalehealth.com/tag/ind) - [ISO 13485: 2003 (1)](https://blog.scalehealth.com/tag/iso-13485-2003) - [ISO90003:2004 (1)](https://blog.scalehealth.com/tag/iso900032004) - [Intellectual Property (1)](https://blog.scalehealth.com/tag/intellectual-property) - [International Electrotechnical Commission (1)](https://blog.scalehealth.com/tag/international-electrotechnical-commission) - [International Organization for Standardization (1)](https://blog.scalehealth.com/tag/international-organization-for-standardization) - [Jira Server (1)](https://blog.scalehealth.com/tag/jira-server) - [Key Terms (1)](https://blog.scalehealth.com/tag/key-terms) - [Labeling (1)](https://blog.scalehealth.com/tag/labeling) - [Liability (1)](https://blog.scalehealth.com/tag/liability) - [MDSAP (1)](https://blog.scalehealth.com/tag/mdsap) - [METRC (1)](https://blog.scalehealth.com/tag/metrc) - [MHLW/PMDA (1)](https://blog.scalehealth.com/tag/mhlw-pmda) - [Management Controls (1)](https://blog.scalehealth.com/tag/management-controls) - [Masks (1)](https://blog.scalehealth.com/tag/masks) - [Medical Device Single Audit Program (1)](https://blog.scalehealth.com/tag/medical-device-single-audit-program) - [Medical Marijuana (1)](https://blog.scalehealth.com/tag/medical-marijuana) - [Ministry of Health, Labour and Welfare (1)](https://blog.scalehealth.com/tag/ministry-of-health-labour-and-welfare) - [Myths (1)](https://blog.scalehealth.com/tag/myths) - [New Approach Directives (1)](https://blog.scalehealth.com/tag/new-approach-directives) - [New Drug Application (1)](https://blog.scalehealth.com/tag/new-drug-application) - [Nonconformity (1)](https://blog.scalehealth.com/tag/nonconformity) - [PCCP (1)](https://blog.scalehealth.com/tag/pccp) - [PRD (1)](https://blog.scalehealth.com/tag/prd) - [Pandemic (1)](https://blog.scalehealth.com/tag/pandemic) - [Part 11 (1)](https://blog.scalehealth.com/tag/part-11) - [Part 820.30 (1)](https://blog.scalehealth.com/tag/part-820-30) - [Performance Tests (1)](https://blog.scalehealth.com/tag/performance-tests) - [Preliminary Screening (1)](https://blog.scalehealth.com/tag/preliminary-screening) - [Project Deliverables (1)](https://blog.scalehealth.com/tag/project-deliverables) - [Project Timeline (1)](https://blog.scalehealth.com/tag/project-timeline) - [QA/RA (1)](https://blog.scalehealth.com/tag/qa-ra) - [QMSR (1)](https://blog.scalehealth.com/tag/qmsr) - [Regulatory Options (1)](https://blog.scalehealth.com/tag/regulatory-options) - [SRS (1)](https://blog.scalehealth.com/tag/srs) - [SaMD Risk Classification (1)](https://blog.scalehealth.com/tag/samd-risk-classification) - [SaMD for QMS (1)](https://blog.scalehealth.com/tag/samd-for-qms) - [SiMD (1)](https://blog.scalehealth.com/tag/simd) - [Software Architecture (1)](https://blog.scalehealth.com/tag/software-architecture) - [Sprints (1)](https://blog.scalehealth.com/tag/sprints) - [Substantial Equivalence (1)](https://blog.scalehealth.com/tag/substantial-equivalence) - [TGA (1)](https://blog.scalehealth.com/tag/tga) - [TSC (1)](https://blog.scalehealth.com/tag/tsc) - [Trust Services Criteria (1)](https://blog.scalehealth.com/tag/trust-services-criteria) - [Valid Clinical Association (1)](https://blog.scalehealth.com/tag/valid-clinical-association) - [Validation Testing (1)](https://blog.scalehealth.com/tag/validation-testing) - [Waterfall Method (1)](https://blog.scalehealth.com/tag/waterfall-method) - [Webinar (1)](https://blog.scalehealth.com/tag/webinar) - [Workflow Transitions (1)](https://blog.scalehealth.com/tag/workflow-transitions) - [abbreviated 510(k) (1)](https://blog.scalehealth.com/tag/abbreviated-510k) - [administrative evaluation (1)](https://blog.scalehealth.com/tag/administrative-evaluation) - [medical device quality management system (1)](https://blog.scalehealth.com/tag/medical-device-quality-management-system) - [paperless quality processes (1)](https://blog.scalehealth.com/tag/paperless-quality-processes) - [qms Samd (1)](https://blog.scalehealth.com/tag/qms-samd) - [qms cloud (1)](https://blog.scalehealth.com/tag/qms-cloud) - [refuse-to-accept (1)](https://blog.scalehealth.com/tag/refuse-to-accept) - [rta letter (1)](https://blog.scalehealth.com/tag/rta-letter) - [special 510(k) (1)](https://blog.scalehealth.com/tag/special-510k) - [traditional 510(k) (1)](https://blog.scalehealth.com/tag/traditional-510k) See all ### Subscribe Here - ![sierra-labs](https://blog.scalehealth.com/hubfs/Sierralabs_January2019%20Theme/Images/sierra-labs-logo.png) - © 2022 Sierra Labs, Inc. - Contact Us - [hello@sierralabs.com](mailto:hello@sierralabs.com) - 3415 S. Sepulveda Blvd. Suite 1000 Los Angeles, CA 90034 - (310) 437-8010 - Products - [Sierra Policies & Procedures](https://www.sierralabs.com/policies-procedures) - [Sierra Document Automation](https://www.sierralabs.com/document-automation) - [Sierra Quality Management](https://www.sierralabs.com/quality-management) - [Sierra GxP Cloud Validation](https://www.sierralabs.com/cloud-validation) - Company - [About Us](https://www.sierralabs.com/about)