Are you up to standard and up-to-date?

From Standard to CE Mark

Zwiers ensures compliance of documentation and QMS with the relevant ISO standards, directives, MDR, 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.

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Zwiers Regulatory Consultancy is a ProductLifeGroup Company

ProductLife Group’s mission is to improve human health by delivering regulatory & compliance services for the safe and effective use of medical solutions. PLG supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 150 countries.

Product LIfe Group