REGULATORY AFFAIRS

An in-depth understanding of the regulations applicable to medical devices and the ability to work effectively within this complex environment is of crucial importance to a successful medical device business.

At all stages in the product life cycle, from pre-clinical assessment and clinical trials through CE marking to post market surveillance, MedPass International provides the expert regulatory advice you need. Whether your objective is:

• To initiate or conduct a clinical investigation,
• To obtain CE marking for Europe or market authorization elsewhere,
• To carry out post market evaluations or meet reimbursement conditions,
• To comply with requirements for post-market surveillance and risk management.

…we have the regulatory expertise needed to guide you through the process.

Clinical Evaluations and Investigations

Our expertise in Clinical Regulatory Affairs, especially pertaining to clinical evaluations and investigations under the revision to the medical devices directive 2007/47/EEC, is unparalleled by any other CRO in Europe.

We help companies understand early on which clinical data will be required for CE marking and then help them plan how to complete the necessary trials in an expeditious and cost-effective manner. Our extensive experience in obtaining clinical trial approvals in most of the EU member states ensures that our clients can initiate their trials as soon as possible. And, we have implemented a highly efficient SAE reporting system to comply with the new reporting requirements.

• CE Marking and Clinical Data Requirements
• Clinical Evaluations
• Regulatory Support for EU Clinical Investigations (EC submissions and CA notifications)
• Pre-market Regulatory Compliance
• Regulatory Vigilance for Clinical Investigations (AESU)
• Audits of EU clinical sites

Regulatory Consulting

Our knowledge of medical device Regulatory Affairs is extensive, ranging from all types of medical device, including active and non-active implants and in-vitro diagnostic devices to products containing human or animal tissues and drug-device combinations. Our experience is broad in dealing with regulatory issues across the whole range of product classes, from 'low risk' devices to active implants.

In spite of the medical device Directives, differences in laws and practices continue to exist between Member State and these can significantly impact on business strategies. Building on our strong working relationships with Government authorities and Notified Bodies across Europe and our long-standing reputation as the foremost European CRO for medical device clinical trials, we provide the in-depth, up to date, country by country knowledge that is crucial to mapping out successful EU regulatory compliance and market penetration strategies for medical devices.

No other medical device consultancy/CRO offers regulatory services with such a broad range of activities and expertise and close links to experienced in-house Clinical Operations and Reimbursement experts.

• Regulatory Strategy
• Classification determinations
• Risk assessment and management
• Biological safety assessments
• CE marking process and compliance assessment
• Human/animal tissue products
• Communication with CAs and Notified Bodies

Adverse Event Surveillance Unit (AESU)

MedPass is the only medical device CRO with a fully dedicated unit for adverse event management supported by experts with extensive experience in the evaluation and reporting of adverse events throughout the product life-cycle.

Our customized adverse event reporting system enables efficient, timely and cost effective solutions to regulatory reporting requirements by EU authorities.

• SAEs for clinical investigations as per EU requirements
• Vigilance reporting for CE-marked products
• Field Safety Corrective Action (FSCA) handling