Medical Device Post-Market

Meditrial is the Representative trusted by more than 100 firms.
Market access has never been easier.

MEDITRIAL HAS HELPED MEDICAL DEVICE AND IVD COMPANIES WITH REGULATORY COMPLIANCE AND MARKET ENTRY SINCE 2008.

WITH OFFICES IN EUROPE AND THE US, MEDITRIAL OFFERS A WIDE RANGE OF MARKET ACCESS SERVICES, INCLUDING REGULATORY COMPLIANCE, CONSULTING, DEVICE REGISTRATION, AND IN-COUNTRY REPRESENTATION.

European Representative

Meditrial has helped over 500 start-up and mid-size companies gain a foothold in Europe. Acting as strategic partner, we help you comply with the European legal requirements and establish constructive relationships with Competent Authorities, Notified Bodies, hospital networks, the European Commission, and industry associations. We operate according to the European Commission guideline MEDDEV 2.5/10.

Quality System Support

Why choose Meditrial for your Quality Management System? Being certified by ISO 9001:2015, our company will help to customize your own system, according to your business size and needs. We’ve been doing this for years, always aiming at continuous improvement and integrating procedures with the best IT solutions.

Swiss Representative

Using the industry’s best practices and high-end expertise, Meditrial’s specialized team will support you in providing solutions in compliance with the Swiss Regulations.

Labeling Validation

Labeling must meet the requirements of Quality System regulations with respect to legibility and adhesion ensuring that correct labeling is always compiled by following the harmonized standards and expert guidance.

Device Registration

Meditrial’s regulatory and quality experts will guide you and assist you step by step in achieving, in the most efficient manner, your medical device’s registration.

Vigilance Surveillance

Meditrial will help you in the reporting of serious incidents and field safety corrective actions, to the relevant competent authorities, analysing negative trends vs. risk management documentation.

Free Sales Certificates

Does your medical device need approval in Europe? Then you require our CFS services. With the free sales certificates you will be able to market your device in the large European arena.

Compliance Audit

Compliance audit is a tough land to explore if you don’t know the right path. Meditrial can help in reviewing your organization adherence to regulatory guidelines, such as GDPR, new upcoming ISO amendments and brand new MDR requirements.
Let us do that for you.

IN-COUNTRY REPRESENTATION

Meditrial serves as a strategic partner, helping companies comply with legal requirements and establish constructive relationships with authorities, payors, hospital networks and academic associations.

POST-MARKET SURVEILLANCE

We provide post-market compliance solutions, incident reporting, and vigilance support driven by a life-cycle approach to device safety and effectiveness.