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CE marking of medical devices and
access to EU and non-EU
Medical Device Regulations & Compliance
- EU MDR 2017/745
- Brazilian RDC 751/2022
- Korean Medical Devices Act
- FDA: 21 CFR part 820
Demonstration of compliance with applicable regulations
Preparation, submission, and follow-up of the technical file
Communication
Referent contact point with regulatory authorities, the notified body, EUDAMED (centralized European database on medical devices)
Processes
Guidance for the development of processes (design control), clinical evaluation, manufacturing process validation, and post-market surveillance
Clinical Trial
Guidance for obtaining regulatory approval for a clinical trial (pre-market)
Market Access
Registration of medical devices in Europe and outside Europe
Product Compliance
Sterilization/Bioburden/Endotoxin Standards
- ISO 11135
- EN 556-1
- AAMI TIR-28
- AAMI TIR-17
- AAMI TIR 16
- ISO 11737 series
- ISO 11138-2
Biocompatibility Standards
- ISO 10993 series
Cleanroom & Biocontamination control Standards
- ISO 14644 series
- ISO 14698-1 & 2
Packaging Standards
- ISO 11607-1 & 2
- ASTM test methods
Labeling Standards
- ISO 15223-1
- ISO 20417
Active implants Standards
- ISO 14708 series
Risk management Standard
- ISO 14971
Usability Standards
- IEC 62366-1 & 2
Software Development Standard
- IEC 62304
Consulting Services
- Strategic and operational guidance on product Compliance demonstration
- Second opinion
Quality Management System (QMS) Compliance
Medical Devices Standards
- ISO 13485
- FDA: 21 CFR Part 820
- RDC 665/2022(B-GMP Brazil)
- Medical Device Act (K-GMP Korea)
Multi-sector Standard
- ISO 9001
Information security Standard
- ISO/IEC 27001
Services
- Consulting-Strategic and operational guidance in creation, improvement, maintenance, performance measurement of the QMS
- Diagnosis, GAP analysis
- Drafting procedures and documents
- Implementation, operationalization
- Internal and supplier audits; management of external audits and inspections
- Operational management (non-conformities, CAPA, changes, document management)
- Team & project management
- Support for implementing information security, cybersecurity and GDPR requirements
Testing, laboratory and Quality Control (QC)
Testing methods Standards
- ASTM and others
Testing & calibration laboratories Standard
- IEC/ISO 17025
Services
- Laboratory and team management
- Test method validation
- Determine product conformity based on specifications
Acting as the “Person Responsible for
Regulatory Compliance” (PRRC)
Accountability For Compliance
- Medical devices (batch release)
- The technical file
- Declarations including the EU Declaration of Conformity
- Implementation of post-market surveillance and vigilance processes