From Standard to CE mark
Zwiers ensures compliance of documentation and QMS with the relevant ISO standards, Directives, Regulations and Guidance Documents. For your medical devices, combination/borderline products or IVDs.
- Notified body interactions
- CE classification
- Competent authorities interactions
- ISO 13485 QMS
- Regulatory strategy plan
- Clinical and biological safety evaluations
- MDR gap analysis
- Risk management plan, analysis and report
- Instructions for Use
- Vigilance and post-market surveillance
- Person Responsible for Regulatory Compliance (PRRC), Read more
Whether it concerns ISO 13485 auditing, writing and composing technical files or managing the approval process with the notified bodies; we have the staff with the experience and dedication to support you.
Up to standard and up to date?