Quality assurance for SaMD and AI medical devices
Quality assurance for SaMD and AI medical devices
We help manufacturers of SaMD, AIaMD, and connected medical devices build and maintain quality management systems that meet EU MDR and FDA QMSR requirements.
Quality management systems for EU MDR and FDA
Quality management systems for EU MDR and FDA
United States
Since 2 February 2026, the FDA Quality Management System Regulation (QMSR, 21 CFR Part 820) incorporates ISO 13485:2016 by reference. A well implemented ISO 13485 system is now the foundation for FDA compliance, complemented by FDA specific requirements for complaint handling, medical device reporting and records.
- QMSR gap assessment and transition from the former QSR
- Complaint handling and medical device reporting (21 CFR Part 803)
- Corrections and removals (21 CFR Part 806)
- Electronic records and signatures (21 CFR Part 11)
Europe
Under the EU MDR 2017/745, manufacturers must operate a quality management system proportionate to the risk class of their device. ISO 13485:2016 is the harmonised standard used to demonstrate conformity, and for most software devices classified under Rule 11 the Notified Body assesses both your QMS and your technical documentation before CE marking.
- QMS setup and implementation to ISO 13485
- Gap assessment against MDR Article 10 and Annex IX
- Procedures for PMS, vigilance and person responsible for regulatory compliance (PRRC)
Other markets
We support MDSAP readiness and prepare technical documentation in the IMDRF format for markets such as Canada, Australia, Brazil and Japan.
United States
Since 2 February 2026, the FDA Quality Management System Regulation (QMSR, 21 CFR Part 820) incorporates ISO 13485:2016 by reference. A well implemented ISO 13485 system is now the foundation for FDA compliance, complemented by FDA specific requirements for complaint handling, medical device reporting and records.
- QMSR gap assessment and transition from the former QSR
- Complaint handling and medical device reporting (21 CFR Part 803)
- Corrections and removals (21 CFR Part 806)
- Electronic records and signatures (21 CFR Part 11)
Europe
Under the EU MDR 2017/745, manufacturers must operate a quality management system proportionate to the risk class of their device. ISO 13485:2016 is the harmonised standard used to demonstrate conformity, and for most software devices classified under Rule 11 the Notified Body assesses both your QMS and your technical documentation before CE marking.
- QMS setup and implementation to ISO 13485
- Gap assessment against MDR Article 10 and Annex IX
- Procedures for PMS, vigilance and person responsible for regulatory compliance (PRRC)
Other markets
We support MDSAP readiness and prepare technical documentation in the IMDRF format for markets such as Canada, Australia, Brazil and Japan.
An ISO 13485:2016 compliant QMS can support both EU MDR conformity assessment and FDA QMSR compliance, from design controls and ISO 14971 risk management to CAPA and supplier controls. Book a call with our QA experts for a gap assessment.
Training
Training
We offer on site and remote training tailored to software and AI teams:
- ISO 13485 and QMSR essentials
- IEC 62304 for developers
- Risk management with ISO 14971
- Design controls and documentation
- Internal auditing
- Notified Body audit and FDA inspection preparation
Design controls and risk management
Design controls and risk management
- Implementation of design and development procedures under ISO 13485
- Design reviews, traceability and design history documentation
- Risk management files according to ISO 14971:2019
- Usability engineering files according to IEC 62366
QA for medical device software and AI
Software brings its own risks, such as frequent releases, third-party components, cybersecurity threats, and, for AI, data and model management. We help your development team work in an agile way while staying compliant.
- Software development lifecycle procedures aligned with IEC 62304
- Health software safety and security aligned with IEC 82304 and IEC 81001-5-1
- Software verification and validation that withstands Notified Body and FDA review
- SOUP and third-party component management
- Data management, model validation, and change control for AI medical devices
- Validation of tools and computerized systems used in your QMS
Audits and gap assessments
- Gap assessments against ISO 13485, EU MDR, FDA QMSR, MDSAP, and ISO 14971
- Internal audits and supplier audits
- Mock Notified Body audits and FDA inspection readiness
- CAPA improvement and closure of audit findings
- Response to FDA 483 observations and warning letters
Technical documentation
- Technical documentation according to MDR Annex II and Annex III
- General Safety and Performance Requirements (GSPR) checklists
- Review of technical documentation before Notified Body submission
- Support with Notified Body questions and nonconformities
Post market surveillance and vigilance
- PMS plans, PMS reports and Periodic Safety Update Reports (PSUR)
- Vigilance procedures for serious incidents and field safety corrective actions
- Complaint trending and feedback into risk management
QA for medical device software and AI
Software brings its own risks, such as frequent releases, third-party components, cybersecurity threats, and, for AI, data and model management. We help your development team work in an agile way while staying compliant.
- Software development lifecycle procedures aligned with IEC 62304
- Health software safety and security aligned with IEC 82304 and IEC 81001-5-1
- Software verification and validation that withstands Notified Body and FDA review
- SOUP and third-party component management
- Data management, model validation, and change control for AI medical devices
- Validation of tools and computerized systems used in your QMS
Audits and gap assesments
- Gap assessments against ISO 13485, EU MDR, FDA QMSR, MDSAP, and ISO 14971
- Internal audits and supplier audits
- Mock Notified Body audits and FDA inspection readiness
- CAPA improvement and closure of audit findings
- Response to FDA 483 observations and warning letters
Technical documentation
- Technical documentation according to MDR Annex II and Annex III
- General Safety and Performance Requirements (GSPR) checklists
- Review of technical documentation before Notified Body submission
- Support with Notified Body questions and nonconformities
Post market surveillance and vigilance
- PMS plans, PMS reports and Periodic Safety Update Reports (PSUR)
- Vigilance procedures for serious incidents and field safety corrective actions
- Complaint trending and feedback into risk management