Medical Device Academy
Medical Device Academy is a quality and regulatory consulting firm dedicated to helping medical device companies navigate complex regulations, improve quality systems, and streamline product development. They focus on training, consulting, and providing resources to ensure compliance with FDA, ISO, and international standards, with a special emphasis on FDA submissions, risk management, usability engineering, sterilization validation, cybersecurity, and supply chain management.
Industries
Nr. of Employees
small (1-50)
Medical Device Academy
Not specified in the content
Products
510(k) course series (webinars, templates, eBook)
A compilation of webinars, electronic templates for premarket submissions, and an eBook describing a structured approach to prepare 510(k) submissions.
Human factors training series and template bundles
Training series and template bundles covering use specification, known use-errors search, task analysis, formative/summative testing protocols, URRA templates, and participant screening/data collection forms.
SYS-031 EO sterilization validation procedure
Documented EO sterilization validation procedure aligned with ISO 11135-1, defining PQ/MPQ/PPQ steps, EO residual testing, and revalidation/requalification criteria for outsourced contract sterilization.
Benchtop Performance Testing Webinar and report template
On-demand webinar explaining how to prepare benchtop performance testing summaries and a template for non-clinical performance test reports suitable for eSTAR attachments.
Biocompatibility webinar and STED template bundle
Webinar and deliverables explaining how to prepare biocompatibility testing sections for 510(k) and CE technical files, including a STED biocompatibility testing template, slide deck, and recorded session.
Use error and abnormal use training webinar
On-demand webinar and decision-tree work instruction to identify and classify use errors and abnormal use, with a short video and downloadable decision-tree form.
510(k) course series (webinars, templates, eBook)
A compilation of webinars, electronic templates for premarket submissions, and an eBook describing a structured approach to prepare 510(k) submissions.
Human factors training series and template bundles
Training series and template bundles covering use specification, known use-errors search, task analysis, formative/summative testing protocols, URRA templates, and participant screening/data collection forms.
SYS-031 EO sterilization validation procedure
Documented EO sterilization validation procedure aligned with ISO 11135-1, defining PQ/MPQ/PPQ steps, EO residual testing, and revalidation/requalification criteria for outsourced contract sterilization.
Benchtop Performance Testing Webinar and report template
On-demand webinar explaining how to prepare benchtop performance testing summaries and a template for non-clinical performance test reports suitable for eSTAR attachments.
Biocompatibility webinar and STED template bundle
Webinar and deliverables explaining how to prepare biocompatibility testing sections for 510(k) and CE technical files, including a STED biocompatibility testing template, slide deck, and recorded session.
Use error and abnormal use training webinar
On-demand webinar and decision-tree work instruction to identify and classify use errors and abnormal use, with a short video and downloadable decision-tree form.
Services
Consulting to prepare and submit 510(k), De Novo, PMA, 513(g), and pre-submission packages, including document drafting, test-plan development, and interaction planning with regulators.
Provision of quality management system procedures, templates, and implementation support to achieve compliance with ISO 13485, MDSAP, and FDA QMSR requirements.
Independent audit services including internal system audits, supplier audits, MDSAP-aligned audits, remote audits, audit scheduling, and audit reporting with flat-fee quotations.
Consulting and training for usability engineering tasks including use specification, known use-error searches, task analysis, URRA, and formative/summative usability testing protocol/report preparation.
Assistance with ethylene oxide sterilization validation planning, performance qualification (MPQ/PPQ), EO residual testing strategies, and requalification frequency assessment per ISO 11135 and ISO 10993-7.
Advisory on selecting and contracting with an FDA US agent, defining scope of service, and integration of the US agent into supplier qualification and FDA registration processes.
Consulting to prepare and submit 510(k), De Novo, PMA, 513(g), and pre-submission packages, including document drafting, test-plan development, and interaction planning with regulators.
Provision of quality management system procedures, templates, and implementation support to achieve compliance with ISO 13485, MDSAP, and FDA QMSR requirements.
Independent audit services including internal system audits, supplier audits, MDSAP-aligned audits, remote audits, audit scheduling, and audit reporting with flat-fee quotations.
Consulting and training for usability engineering tasks including use specification, known use-error searches, task analysis, URRA, and formative/summative usability testing protocol/report preparation.
Assistance with ethylene oxide sterilization validation planning, performance qualification (MPQ/PPQ), EO residual testing strategies, and requalification frequency assessment per ISO 11135 and ISO 10993-7.
Advisory on selecting and contracting with an FDA US agent, defining scope of service, and integration of the US agent into supplier qualification and FDA registration processes.
Expertise Areas
- Regulatory submissions and e-submission workflows (510(k), De Novo, PMA, eSTAR)
- Quality management systems and audit readiness (ISO 13485, QMSR, MDSAP-style audits)
- Human factors and usability engineering (use specification, URRA, formative/summative testing)
- Software lifecycle, cybersecurity, and SaMD documentation (IEC 62304, SSDLC, SBOM, threat modeling)
Key Technologies
- Electronic regulatory submission templates and workflows (eSTAR/eCopy)
- IEC 62304 software lifecycle and software validation practices
- Secure Software Development Lifecycle (SSDLC) artifacts and SBOM management
- EO sterilization validation methods (PQ, MPQ, PPQ) and PCD/BI use
News & Updates
FDA eSTAR v5.5 – What’s new?
Deep dive into the newest version of the FDA eSTAR, version 5.5, released on February 12, 2025, including updates on PMA content, cybersecurity documentation, and biocompatibility evaluation.
Benchtop Performance Testing Webinar
Training on how to prepare benchtop performance testing reports for FDA eSTAR submissions, including format and supporting evidence.
510(k) Labeling and UDI Requirements Webinar
Guidance on preparing FDA eSTAR labeling sections and addressing UDI barcode requirements for medical devices.
FDA Human Factors Guidance
Final guidance on applying human factors and usability engineering to medical devices, including design and risk management considerations.
Reprocessed Single-Use Devices – 510(k) Optimization
Strategies for preparing FDA 510(k) submissions for reprocessed single-use devices, including labeling, biocompatibility, and performance testing.
Sterility Validation and EO Requalification Procedures
Guidance on sterilization validation, requalification, and reprocessing of ethylene oxide sterilizers and devices.
FDA eSTAR v5.5 – What’s new?
Deep dive into the newest version of the FDA eSTAR, version 5.5, released on February 12, 2025, including updates on PMA content, cybersecurity documentation, and biocompatibility evaluation.
Benchtop Performance Testing Webinar
Training on how to prepare benchtop performance testing reports for FDA eSTAR submissions, including format and supporting evidence.
510(k) Labeling and UDI Requirements Webinar
Guidance on preparing FDA eSTAR labeling sections and addressing UDI barcode requirements for medical devices.
FDA Human Factors Guidance
Final guidance on applying human factors and usability engineering to medical devices, including design and risk management considerations.
Reprocessed Single-Use Devices – 510(k) Optimization
Strategies for preparing FDA 510(k) submissions for reprocessed single-use devices, including labeling, biocompatibility, and performance testing.
Sterility Validation and EO Requalification Procedures
Guidance on sterilization validation, requalification, and reprocessing of ethylene oxide sterilizers and devices.