ISO 13485 CERTIFICATION
Promepla is ISO 13485 certified and operates a documented Quality Management System (QMS) covering every stage of design, industrialisation, manufacturing, and quality control.
REGULATORY AFFAIRS SUPPORT
Our Regulatory Affairs experts work alongside customers to develop effective regulatory strategies, prepare technical documentation, and support product registrations, ensuring compliance and successful market access worldwide.
Ensuring quality and compliance at every stage
Quality Assurance & Regulatory Affairs
Quality Assurance & Regulatory Affairs
ISO 8 clean rooms
3500m²
dedicated professionals
450
injection moulding machines
27
extrusion lines
7
Regulatory Affairs & International Registrations
Regulatory strategy
CE marking (download our certificate) and EU technical files
FDA and Health Canada approvals
ANVISA and global registrations
Post-market surveillance
QMS Compliance
Product master files
Design verification and validation
Risk management (ISO 14971)
QMS creation (ISO 13485 / 21 CFR 820)
Biological & Stability Studies
Biocompatibility and sterilisation validation
Bioburden, sterility, and shelf-life studies
Electromedical Device Studies
Electrical safety and EMC testing
Software and usability validation
Already a Promepla customer? If you have a request, please email us at reqcustomer@promepla.com