Interim & project support
- Interim or fractional QA/RA support
- Clearly scoped QA/RA projects for Pharma and MedTech
- Senior sounding board, second opinion and independent document review
Senior QA/RA and practical support.
Temporary and project-based support for Pharma, MedTech and other regulated organisations.
Regulatory strategy & positioning
- EU MDR, intended purpose, claims and classification
- Implications for product, evidence, organisation and the route towards CE marking
- Technical documentation, gap analysis and second opinion
Product safety & material compliance
- Biocompatibility, ISO 10993 and product safety
- Food-contact and migration testing
- REACH and chemical compliance
QA & Quality Systems
- ISO 13485 QMS and QMS review
- ISO 14971 risk management
- Deviations, CAPA and change control
- QA/QC, gap assessment and process improvement