---
title: Embrace Agile in SaMD to stay competitive!
description: Learn how to implement Agile into your SaMD development and also stay compliant.
image: https://blog.scalehealth.com/hubfs/Waterfall-to-Agile-Leap-2.jpg
---
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# Embrace Agile in SaMD to stay competitive!
Posted by [Sierra Labs](https://blog.scalehealth.com/author/sierra-labs) on Mar 27, 2019 11:19:32 AM
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Learn how to implement Agile into your SaMD development and also stay compliant.
The Agile methodology of software development by continuous iteration is gaining momentum in the regulated product-development market. The Agile methodology in med-tech is a non-linear workflow with multiple process segmentations and iterations. Here, rapid execution gets an upper hand over careful planning and documentation.
At first glance this method might seem to contradict the FDA-mandated, linear, stringent medical device manufacturing norms. But in 2012, the Association for the Advancement of Medical Instrumentation released the AAMI TIR45 guidelines to help developers achieve maximum compliance using Agile methodology, which has in turn helped Agile gain popularity among developers and med-tech companies.
**Apprehensions and Possible Solutions**
The Agile methodology deviates from the conventional, linear, sequential process-flow approach. However, presenting the final product linearly does not necessitate its developmental cycle to be linear as well.
Technically, it is almost impossible to concretely define one’s requirements without some preliminary, experimental architecture and development work to validate the necessity of a requirement which is well posed and technologically feasible. This highlights the need for optimal iterations for maximum efficiency in process-flow and subsequent product development.
A clear idea is derived upon when cross-functional teams covering all the important domains of software development like planning, designing, developing and validating, work on successive iterations of the product, typically over fixed time periods. Hence, if done in a controlled fashion and executed optimally, the Agile methodology of medical device software designing holds the potential to improve software design and enhance compliance.
The FDA eventually approved of Agile practices in January 2013. Most med-tech software developers are now vouching for Agile in the med-tech industry, with developers and manufacturers endorsing its importance and appropriateness in the business.
Despite the praise of Agile manifesto for software development, developers are still perplexed. They find themselves in a fix when it comes to judicious and meticulous application of Agile. A decentralized, flexible, iterative model like Agile does not necessarily align with FDA’s stringent regulations on meticulous risk management, mature development processes, and thorough documentation. This makes developers apprehensive about Agile’s compliance with rigid standards like 21 CFR Part 820, ISO 13485, ISO 14971 and IEC 62304.
The AAMI TIR45 attempts to solve these queries and provide clear navigation of adapting to Agile methodology in medical device development.
**Key takeaways from the guidance on Agile**
The AAMI TIR45 is neither a standard nor a recommended practice, but is instead designed to dig deep into existing standards and find synergies in terms of concepts and practices for the Agile methodology. It provides information in terms of documentation, evolutionary design and architecture, traceability, verification and validation, managing changes and “done” criteria.
The document is titled *Guidance on the use of AGILE practices in the development of medical device software*. It describes certain pre-requisites for successful implementation of Agile in med-tech firms.
The different prerequisites highlighted in this document are:
| - It is mandatory for the application of Agile processes to abide by the requirements specified in the organization’s Quality Management System (QMS) | - Formulation of robust strategies on change management is mandatory. This ensures a product quality of the highest order and an adequate risk level |
| --- | --- |
| - One should undertake a detailed life cycle modelling in order to maintain discipline in the operation of mature development processes | - Sufficient documentation should be maintained in order to meet quality standards of both internal and external regulatory bodies |
**Incorporate Agile into your Life Cycle Management**
There is an overall hierarchical flow of development processes. There are four layers of development according to the Agile framework:
Fig 1: Layers of Development in Agile Methodology
The activities executed in the layers of functionality are aligned with the IEC 62304 requirements, ensuring that all regulatory requirements are met while employing the Agile methodology in med-tech.
A successful quality management system can be implemented effectively using Agile methods in specific work-environments without compromising on compliance.
Design inputs and outputs are two categories that often confuse developers, as they do not exist in isolation in an Agile environment. This document specifies the design inputs as user stories, along with their defined acceptance criteria. Design outputs are specified as artifacts like architecture and design elements, code, as well as test cases and their results. This document also sheds light on the importance of non-functional requirements for user stories.
**Valued Outcomes of Using Agile**
The Agile model of med-tech development has its own share of benefits when implemented optimally. Agile helps in developing an initial, experimental architecture and allows for design reviews at the end of each increment, detecting flaws in its earlier stages rather than solely reviewing at the end in a waterfall methodology. This helps reduce cost while also driving a continuous improvement process, enhancing the overall quality of the final product. Continuous incorporation of customer feedback helps in refining the quality parameters even further. Enhancing and prioritizing the backlog throughout the developmental process ensures a closer alignment with customer or market requirements, thus achieving immense precision in an ever-changing market landscape.
And finally, the Agile methodology requires extensive documentation to validate a clear and well-described ‘Definition of Done’ which feeds into the Quality Management System and helps maintain the necessary stringency for successfully tackling compliance audits. To achieve maximum compliance, a lot of med-tech development teams rely on smart tools that provide automated documentation and enhanced collaboration in an accelerated environment that fully supports an Agile environment.
**Want to see how Sierra QMS can help your organization?**
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Topics: [Agile](https://blog.scalehealth.com/tag/agile), [FDA](https://blog.scalehealth.com/tag/fda), [QMS](https://blog.scalehealth.com/tag/qms), [SaMD](https://blog.scalehealth.com/tag/samd), [Medical Device](https://blog.scalehealth.com/tag/medical-device)
## 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)
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- [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)
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- [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)
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- [DTx (3)](https://blog.scalehealth.com/tag/dtx)
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- [FDA Standard (3)](https://blog.scalehealth.com/tag/fda-standard)
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- [Iterative Process (3)](https://blog.scalehealth.com/tag/iterative-process)
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- [Predicate Device (3)](https://blog.scalehealth.com/tag/predicate-device)
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- [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)
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- [Telehealth (3)](https://blog.scalehealth.com/tag/telehealth)
- [eQMS (3)](https://blog.scalehealth.com/tag/eqms)
- [AWS (2)](https://blog.scalehealth.com/tag/aws)
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- [CDER (2)](https://blog.scalehealth.com/tag/cder)
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- [CFR (2)](https://blog.scalehealth.com/tag/cfr)
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- [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)
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- [New Draft (2)](https://blog.scalehealth.com/tag/new-draft)
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- [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)
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- [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)
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- [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)
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- [Myths (1)](https://blog.scalehealth.com/tag/myths)
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- [New Drug Application (1)](https://blog.scalehealth.com/tag/new-drug-application)
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- [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)
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- [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
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