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?

Meet with Zwiers! This email address is being protected from spambots. You need JavaScript enabled to view it.

Zwiers Regulatory Consultancy | Pivot Park | Henry Chesbrough building | Kloosterstraat 9 | 5349 AB Oss | The Netherlands
Zwiers Regulatory Consultancy | Matrix V |Science park 406 | 1098 XH Amsterdam | The Netherlands

Tel +31 (0)6 10489150 | info@az-regulatory.com