--- title: Guidance on HIPAA Compliance for Medical Devices description: Defining HIPAA Compliance as it pertains to your Medical Device Company. image: https://blog.scalehealth.com/hubfs/Hero-045.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. # Guidance on HIPAA Compliance for Medical Devices Posted by [Sierra Labs](https://blog.scalehealth.com/author/sierra-labs) on Sep 17, 2020, 8:38:00 AM - [Tweet](https://twitter.com/share) Defining HIPAA Compliance as it pertains to your Medical Device Company. ![Hero-045](https://blog.scalehealth.com/hs-fs/hubfs/Hero-045.png?width=1600&name=Hero-045.png) HIPAA compliance for healthcare can be a complex web to untangle even more if you are trying to figure out what it means to you and your product. See how or why your organization may fall under HIPAA in this blog. Let’s review what exactly HIPAA is. **What is HIPAA?** The Health Insurance Portability and Accountability Act (HIPAA) was created to provide a baseline for security standards when handling personal health information (PHI). Prior to HIPAA, companies developing medical device that handled patient health information (PHI) had no clear regulatory boundaries. It blurred the regulatory lines especially as technology evolved and was more prominently adopted in the healthcare industry. There was no standard that successfully detailed the best methods or practices for handling PHI let alone transmitting it. The main identifiers that make health information PHI according to HIPAA are: - Names, Dates, SSI, Vehicle Identifiers - Telephone Numbers, Fax Number, Emails, Internet Protocol Addresses, Geographic Data - Certificate Numbers, License Number, Health Plan Beneficiary Number - Biometric identifiers or any unique identifying code or number **Purpose of HIPAA** HIPAA has two main purposes, the first, serving as a guide to identify which patient information qualifies as “protected” and, the second, providing the best practices for setting safeguards. Despite HIPAA establishing these standards, it is the U.S. Department of Health and Human Services (HHS) that enforces the implementation of HIPAA through legislation like the Security rule or Privacy rule. It's important for you to understand the language used in HIPAA so that you have a better grasp of the HIPAA Rules. Two important terms to note that describes the parties involved in HIPAA compliance are found below: - Covered Entities (CE): healthcare providers that transmit information in an electronic form; health plans, such as insurance companies, HMOs, and government programs that pay for care; and healthcare clearinghouses, such as a coding service or revenue cycle management partner. - Business Associates (BA): partners utilized by Covered Entities, such as claims processors, CPA and law firms, quality assurance consultants, and pharmacy benefits managers. There are definite instances in which medical device companies will find themselves defined as a business associate such as if your medical device generates PHI and is working with a covered entity contractually (doctor’s office or hospital). This particular instance means that the device transmitting ePHI should be HIPAA compliant. [If you seek further guidance on developing a HIPAA compliance program, check out this thorough checklist!](https://campaign.sierralabs.com/free-hipaa-compliance-checklist) **Which Devices Need to be HIPAA Compliant** Are you unsure if your medical device is affected by HIPAA standards? Here is a way to find out! If your medical device transmits, receives, or records health information, then it falls under HIPAA compliance.  If you are a startup looking to develop a health app for the healthcare industry, you should take strong consideration of how HIPAA compliance could impact your entire development. Not all health apps need to be HIPAA Compliant such as ones that only require inputting estimated data to chart your own health and fitness goals. But if your app records, stores, manages or shares PHI for/with/on behalf of CEs, then HIPAA in fact does apply. [Developing an eHealth application? Learn how to establish safeguards for HIPAA compliance with our FREE eBook!](https://campaign.sierralabs.com/free-hipaa-hitrust-ebook-ehealth) HHS expects medical devices to be built with the capability to handle sensitive information as well as safeguarding the transmission of data from patients to authorized third parties. **Legal Implications with HIPAA** So what happens if you fall short with HIPAA compliance? A hefty fine. If found in violation of any HIPAA rules, you could face a large fine regardless of intentionality. In the case where the violation is severe, criminal charges could be filed to members of your company. | **Violation Category Section 1176(a)(1)** | **Each Violation** | **Violations of Identical Provision in a Calendar Year** | | --- | --- | --- | | A. Did not know | $100 - $50,000 | $1,500,000 | | B. Reasonable Cause | $1000 - $50,000 | $1,500,000 | | C.i. Willful Neglect - Corrected | $10,000 - $50,000 | $1,500,000 | | C.ii. Willful Neglect - Not Corrected | $50,000 | $1,500,000 | **A Toolset to Manage your SOP Documents** While the complexities of HIPAA may seem overwhelming, those companies that choose to push through are the ones we’ll be talking about for years to come. With the increased cases of data breaches each year, the last thing you want to face is a long list of penalties and lawsuits by not fortifying your HIPAA compliance program. Here at Sierra Lab, we have helped SaMD companies break into the health technology market by designing a concrete regulatory roadmap that fits their business’ needs. We do this by conducting a proper HIPAA Risk Assessment that suits your business size and type identifying the key areas your organization needs to focus on to mitigate potential threats. [Sierra Services](https://www.sierralabs.com/services/) is the first step to achieve HIPAA compliance and other regulatory requirements in the way of launching your product to market. We will guide you every step of the way to ensure your team feels safe and confident on your product’s journey to market. **Need Further Guidance on HIPAA Compliance for Your Medical Device?** **Click Here for a Free Consultation!** [![Sierra Services](https://hubspot-no-cache-na2-prod.s3.amazonaws.com/cta/default/5229980/f8835975-edb1-4771-a4b0-235e2de025aa.png)](https://hubspot-cta-redirect-na2-prod.s3.amazonaws.com/cta/redirect/5229980/f8835975-edb1-4771-a4b0-235e2de025aa) Ask us anything. Topics: [SaMD](https://blog.scalehealth.com/tag/samd), [Data Security](https://blog.scalehealth.com/tag/data-security), [Medical Device Company](https://blog.scalehealth.com/tag/medical-device-company), [Data Privacy](https://blog.scalehealth.com/tag/data-privacy), [Data Requirements](https://blog.scalehealth.com/tag/data-requirements), [SaMD Development](https://blog.scalehealth.com/tag/samd-development), [Software Requirement Specification](https://blog.scalehealth.com/tag/software-requirement-specification), [HIPAA](https://blog.scalehealth.com/tag/hipaa), [Personal Health Information](https://blog.scalehealth.com/tag/personal-health-information), [Health Data](https://blog.scalehealth.com/tag/health-data), [HIPAA Compliance](https://blog.scalehealth.com/tag/hipaa-compliance), [HIPAA Checklist](https://blog.scalehealth.com/tag/hipaa-checklist), [Covered Entities](https://blog.scalehealth.com/tag/covered-entities), [Business Associates](https://blog.scalehealth.com/tag/business-associates), [ePHI](https://blog.scalehealth.com/tag/ephi), [PHI](https://blog.scalehealth.com/tag/phi), [eHealth](https://blog.scalehealth.com/tag/ehealth), [Health Applications](https://blog.scalehealth.com/tag/health-applications) ## 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 - Company - [About Us](https://www.sierralabs.com/about)