The continuous updates of regulatory requirements, ISO/IEC standards and guidelines can be challenging to overview and prepare for.
We can help you with:
- Surveillance of upcoming changes in relevant standards and regulations for your product types. Assess their impact.
- Form the strategy for regulatory compliance as mandated by EU MDR & IVDR (Art. 10)
- Support in interpretation of guidence documents
- Adverse event and Vigilance reporting to Competent Authorities and the FDA
- Planning and conducting Field Safety Corrective Actions and recalls
Contact me for further information
Office +46 46 286 88 90 or send me an e-mail