How do you ensure regulatory compliance throughout the entire lifecycle of your medical device?

Regulatory compliance for medical devices means meeting all applicable requirements from the initial idea to post-market surveillance. This can only be achieved with a well-thought-out strategy that integrates documentation, clinical evidence, software, quality management, and post-market surveillance.

What makes regulatory compliance successful:

Technical documentation and verification & validation
Software compliance & cybersecurity
Clinical affairs, regulatory affairs & QM
Post-market surveillance (PMS)
PRRC and representative services
Digitalization of regulatory processes (RIMS)
Knowledge transfer through the Metecon Academy

Metecon is your strategic partner throughout the entire product lifecycle. We listen, think along, and create tailored solutions for the approval of your product.

Benefit from our experience, strategic foresight, and operational implementation strength – so that your product not only enters the market but also remains there.

Our expertise at a glance

Technical documentation
The results of Biological Safety, Risk Management, and Usability are documented here: From creation to ongoing maintenance, we ensure MDR-compliant documentation for your product approval.

Medical device software
Whether standalone software (SaMD) or embedded systems – we guide you through regulatory requirements and ensure compliance.

Verification & validation
Structured testing strategies, evidence documentation, and preclinical testing to minimize risks and accelerate your development.

Clinical affairs & Post-Market Surveillance (PMS)
Clinical evaluations, PMCF strategies, and post-market surveillance – we support you throughout the entire clinical process.

Regulatory Affairs & QMS
From market approval and international registrations to implementing a compliant quality management system (QMS) – we ensure a smooth process.

PRRC and representative services
We act as your PRRC and provide EC-REP and CH-REP services to ensure seamless and compliant market access in Europe and Switzerland.

Regulatory affairs software & digitalization
The future of regulatory affairs is digital – we help you select and implement regulatory information management systems (RIMS) and optimize your regulatory workflows.

Metecon Academy
Workshops, training sessions, and strategic knowledge transfer for regulatory affairs, QMS, and clinical evaluations – ensuring structured and compliant processes in your company.

Let’s discuss your regulatory challenges! Contact us for a free initial consultation.