ESPL provides expertise and support to our clients in the medical device industry with:
- Coordinating, preparing, and supporting clients with Notified Body (NB), Competent Authority (CA) and other regulatory agency advice meetings;
- Planning and strategy for medical device submissions in the EEA, North America and Australia:
o Identifying relevant ISO, IMDRF and other legislative requirements,
o Preparation of strategy documents and risk analyses
- Construction of clinical trial applications / notifications and liaison with device ethics committees in support of clinical studies.
- Liaising with regulatory agencies to seek approval for new medical devices or updates / new models of existing devices, including:
o Development of the Essential Principles / Essential Requirements checklists,
o Providing framework support for implementation of ISO 13485 Quality Management Systems, and supporting certification where appropriate
o Planning, drafting and submissions support for CE marking / 510(k) and PMA applications
o Life cycle management of medical device files.
- ESPL has specific expertise in novel drug-device combinations, drug-device delivery systems and radiological devices (such as radioactive implants).
For more information on how ESPL can support your business, contact us via the form below, and we can arrange a consultation.