Europe Regulatory ServicesA Quality Management System (QMS) is fundamental requirement for medical device manufacturers seeking access to the European market. Manufacturers are required to establish, document, implement, maintain, and continually improve a QMS that ensures compliance with regulatory requirements. Aligning your QMS with EN ISO 13485 (harmonized standard) not only supports MDR compliance but also strengthens overall product quality, risk management, and market credibility.
QMS address at least following aspects:
Our Services Include
- Risk Management System Development as per EN ISO 14971.
- Clinical Evaluation and PMS/PMCF Integration.
- Design and Development Control Documentation.
- Supplier Qualification and Outsourcing Control.
- Manufacturing and Process Control Documentation.
- CAPA and Nonconformity Management.
- Document and Record Control System Establishment.
- Regulatory Compliance Strategy: Ensuring adherence to MDR requirements and applicable harmonized standards
- Risk Management: Systematic identification, evaluation, and control of risks throughout the product lifecycle
- Clinical Evaluation & PMS: Integration of clinical data, post-market surveillance (PMS), and post-market clinical follow-up (PMCF)
- Design & Development Controls: Structured processes for safe and effective device development
- Supplier & Outsourcing Control: Qualification and monitoring of critical suppliers and subcontractors
- Production & Process Controls: Ensuring consistent manufacturing quality
- Corrective and Preventive Actions (CAPA): Effective handling of nonconformities and continuous improvement
- Documentation & Record Control: Maintaining technical documentation and QMS records as per regulatory expectations.
A well-implemented QMS ensures traceability, accountability, and compliance across all these areas.
MEDREG assist medical device manufacturers in establishing, implementing, and maintaining Quality Management System (QMS) requirements aligned with EN ISO 13485 and applicable EU Regulation requirements to support compliance, product quality, and continual improvement.
