Regulatory Compliance Throughout the Entire Product Lifecycle for Medical Devices

Regulatory requirements for medical devices are complex, constantly evolving, and resource-intensive. Ensuring market access and maintaining long-term compliance requires a well-thought-out strategy—from the initial product idea to post-market surveillance.

As your trusted partner, we provide expert support in technical documentation, software compliance, verification & validation, clinical affairs & PMS, regulatory affairs & QMS, as well as PRRC and representative services. We also assist you in the digital transformation of regulatory processes and the implementation of regulatory affairs software (RIMS).

Knowledge transfer for your strategy: Through the Metecon Academy, we offer tailored workshops and training sessions to equip your team with the expertise needed to navigate current and future regulatory challenges.

Benefit from our experience, strategic foresight, and hands-on execution—ensuring that your product not only reaches the market but stays there successfully.

Our expertise at a glance

Technical documentation
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.