Through the combined work of regulatory, statistical and medical writing experts DLC supports medical device and IVD companies in:
- Defining study design, objectives, endpoints and sample size according to applicable US and/or European regulatory requirements
- Developing/reviewing clinical protocols for studies with medical devices in accordance with EN ISO 14155:2011
- Developing/reviewing protocols for IVD performance evaluation studies in accordance with with US and/or European requirements
- Developing protocols for post market clinical follow up (PMCF) studies
