Clinical
Running a clinical trial?
Developing a CEP or CER?
PMCF questions?
No matter what classification of device, digital solution or IVD that you have, clinical strategy, clinical evidence and clinical evaluation are central to ensuring your product is safe and suitable for human use, for approval and access to global markets.
In order to effectively market your device and generate sales, you need to consider early in the development process the clinical elements and to efficiently implement the right integrated regulatory and clinical strategy.
Our Clinical Services Include:
-
Integrated clinical and regulatory approach from first-in-human / early-stage feasibility studies through to pivotal trials
-
Clinical trial strategy, design and management of clinical investigations (ISO 14155 / MDR / FDA)
-
FDA Q-Sub and related activities
-
Competent Authority, Ethics Committee and related clinical study submissions and approvals
-
Clinical Evaluation Plans and Reports
-
Clinical Literature Search and Reviews
-
Post Market Clinical Follow-Up (PMCF), including registries
-
UK Legal Representative, UK Responsible Person
-
Clinical Safety DCB0160 and DCB0129
-
Digital Technology Assessment Criteria (DTAC)
UK Clinical Submissions
If you are thinking of launching a Clinical Investigation in the UK, watch our ‘How to’ Clinical Submissions 6-part video series.
