With over 10,000 medical devices registered in Europe alone, they are an important element in the healthcare industry and ESPL has the expertise to help you navigate the requirements to bring your device to market.
- 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 (European Economic Area), North America and Australia:
- Identifying relevant ISO (International Standards Organisation), IMDRF (International Medical Device Regulators Forum) and other legislative requirements,
- 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:
- Development of the Essential Principles / Essential Requirements checklists
- Providing framework support for implementation of ISO 13485 Quality Management Systems, and supporting certification where appropriate
- Planning, drafting and submissions support for CE marking/ UKCA marking / 510(k) and PMA (Pharmaceutical Manufacturers Association) applications
- 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 and we can arrange a consultation.
“The diversity of medical devices is both breath-taking and challenging: That’s what makes them a fascinating area to work in.” – Jason Collins, Managing Director
We provide flexible and comprehensive support for clinical trial, MAA and NDA submissions for both small molecule and biological products. We can prepare all relevant documents, review your documents, and publish submissions. We can also act as an MA Holder in the UK and EU.
ESPL has significant experience in supporting clients with local and global regulatory strategies, as well as preparing and coordinating advice from regulatory agencies for a wide range of different therapeutic areas with both SME’s and big Pharma. We also support clients with PRIME, PIP, Orphan, ATMP and drug-device applications.
Our own in-house publishing team can publish and maintain your e-CTD for EU and US submission, including ASMFs/DMFs and CEPs. The team can publish your documents, and submit them via CESP, MHRA Portal, FDA ESG, etc.
At ESPL we offer a comprehensive regulatory affairs training package. In 2012 the principal trainer, Helen Erwood, was nominated for the TORPA “inspiration” award, and several team members lead and present at TOPRA training courses.
Regulatory activities don’t just stop when the MAA/NDA is granted, which is why ESPL provides support for the full life cycle of your product. We can provide services to maintain/vary your licences, to manage Sunset Clause submissions, and to extend your regulatory licences into new markets.