Services

Goal setting with wooden blocks and checkmarks
Regulatory strategy for market entry (EU, US and Australia mainly) including:
Applicable regulations
Device classification
Predicate search, device classification and associated pre-market process for the US
Conformity assessment procedure for the EU
Key requirements for the QMS
Key requirements for the technical documentation/file
Expected bench testing and clinical data
Roadmap to market entry
Anticipated review timeframes and related fees
Full support for CE Marking including:
Quality Management System (QMS) implementation
Technical documentation preparation
Support during Notified Body (NB) Conformity Assessment
Registrations in EUDAMED
Literature search
Regulatory writing including:
Quality Manual
Standard Operating Procedures (SOPs)
Intended Purpose of The Device
Risk Management File
Literature Search Protocol and Report
State Of The Art Report
Similar Devices Report
Performance Evaluation Plan
Scientific Validity Report
Performance Study Plan and Report
Analytical Performance Report
Stability Study Protocol and Report
Usability Test Protocol and Report
Usability Report
Instructions For Use
Labels
Investigator’s Brochure
Patient Information Sheet
Informed Consent
Clinical Performance Report
Performance Evaluation Report
Post-Market Performance Follow-Up (PMPF) Plan and Report
Post-Market Surveillance Report
Periodic Safety Update Report (PSUR)
Summary of Safety and Performance (SSP)
Full support for Performance Study Application in EU
In English
In French
Regulatory compliance on-going support
Short questions – Quick responses
Training
Tailored to your needs
Audit
Internal audit
Supplier audit
Person responsible for regulatory compliance (PRRC) for EU
TEAM-PRRC Member

Ensure IVD regulatory compliance with expert support

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