Under the new medical device requirements all trials with devices must be conducted in compliance with biomedical or GCP requirements. The regulatory requirements for trial conduct are defined in national law, by the medical device laws and by the ISO 14155. This handy GCP pocket brings the regulatory requirements together in a single consolidated reference aid. Understand the specific regulatory requirements to ensure well-structured, scientifically valid, quality trial data is obtained. A must for anyone involved with medical devices regulatory affairs, quality assurance, clinical research and reimbursement! Including the following annexes: general definitions, the essential requirements, classification rules, clinical evidence rules, adverse event reporting, post-market clinical follow-up, the Declaration of Helsinki, Declaration of the rights of the patient and regulatory references.
The 2nd edition of the international best-selling GCP reference guide combines the updated international medical device regulatory requirements with the ICH Tripartite, national biomedical law, medical device guidance, global harmonisation developments and changes to the ISO 14155. Also included are flowcharts on the device trial process along various explanatory notes.
2nd edition February 2011