Regulatory approval

Regulatory Services.
Strategic path for expedited market approval.

Meditrial Europe works with customers to formulate and execute pre-clinical and clinical strategies exclusively serving the medical device and IVD industry. Our dedicated experts are focused on producing the most meaningful, comprehensive, and submission-ready compilation of non-clinical and clinical data – to ensure compliance with regulation and guarantee approval for marketing or clinical trial.

As global regulatory requirements keep evolving, we’re here to help you increase your chances of regulatory approval. Meditrial’s specialized expertise is the foundation for expediting the approval process. We are abreast of changing requirements and industry challenges by participating in the international working groups and taskforces for regulation development. Liasoning with notified body experts and competent authorities, we warrant the appropriate path to market success.

QMS implementation for startups
Quality plan
Development of SOPs
Design control & DHF
Process validation
Subcontractor requirements
Certification audit
Notified body selection
ISO 13485 training

Quality System Compliance

Meditrial gets you ready for certification of your quality management system for any class of medical device, with flexible service based on the complexity of your organization or the legal jurisdiction in which you operate.

CE mark strategy
Technical file
Design dossier
Device labeling
Risk management ISO 14971
Literature review report
Clinical evaluation report
Postmarket clinical followup
Vigilance and surveillance

CE Mark Application

Our integrated team of medical writers, biostatisticians, regulatory specialists, and subject matter experts will pull together the right data to analyze, interpret and package your evidence for expedited CE mark.

Post-approval services. Learn more about Meditrial’s post-approval services for Market Launch dedicated to the medical device industry.

Choose Meditrial as your European Representative.
Meditrial is pleased to put at your disposal our support and recognized reputation as a leading supplier of regulatory and clinical services.