ESPL Regulatory Consulting

Medical Device Submissions

Support regarding medical device clinical trial notifications, ISO 13485 certification, CE marking (including compiling technical files) and local notification procedures prior to marketing.

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.

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