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.
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.
We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you agree.OKPrivacy policy