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?

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