Compliance for medtech manufacturers
Medtech manufacturer services
We offer a strategic approach to market access, methods to reduce regulatory hurdles, and enhanced product safety – allowing you to focus on innovation and business growth while maintaining compliance with global regulatory standards.
Medtech manufacturer's key responsibilities
As a legal manufacturer in Medtech you are fully responsible for meeting the regulatory, quality, and safety requirements issued in your market. Our experienced specialists help you stay abreast and make the right regulatory decisions for your product.
By partnering with our consultants, legal medtech manufacturers gain access to regulatory expertise, risk mitigation strategies, and streamlined compliance processes.
Areas we support:
1. Regulatory compliance & product registration
Ensure compliance with MDR (EU), IVDR, UKCA (UK), and Swissmedic requirements.
2. Quality management system (QMS)
Establish and maintain a compliant QMS in line with ISO 13485 and applicable regulations.
3. Clinical & performance evaluation
Conduct Clinical Evaluations (CERs) or Performance Evaluations (PERs) for IVDs.
4. Market Access & labelling compliance
Compliance with Unique Device Identification (UDI) and labelling requirements. Register products in EUDAMED, UK MHRA, and Swissmedic databases.
5. Post-market surveillance (PMS) & vigilance
Maintain a robust PMS system, including proactive risk monitoring.
6. Supply chain & manufacturing compliance
Supplier qualification, traceability and compliance with material and component sourcing regulations.
Medical device manufacturer services
Our product development support offers you expert guidance in Design Control, Risk Management, Usability Engineering, and other crucial areas in regulatory and quality compliance.
Read more about our compliance services:
Your contact person
Erik Hedner
