TOLEDO, OHIO and MADRID, SPAIN — MARCH 21, 2022 NAMSA, a world leading MedTech Contract Research Organization (CRO) offering global end-to-end
Good clinical practice (GCP) GCP is an international quality standard that governments can transpose into regulations that decide how clinical
A typical consultation we receive at AKRN Scientific Consulting is related to the essential documents required for planning, conducting and closing
Safety reporting is a crucial aspect of a successful clinical investigation for medical devices. In addition to the Good Clinical Practice (GCP),
Acquisition to Enhance Cardiovascular Expertise and Regional Presence in Europe TOLEDO, OHIO and MADRID, SPAIN — MARCH 21, 2022 NAMSA, a
The implementation of the Medical Device Regulation (EU) 2017/745 (hereinafter referred to as MDR) has set new requirements for performing clinical
The concept of equivalence in the European’ MedTech sector In Europe, medical device manufacturers with products on the market have long used
MDR Clinical Evaluation: definitions EU Regulation 2017/745, commonly referred to as Medical Device Regulation (MDR), requires the assessment of
If you are failing to plan, you are planning to fail. It is crucial for all medical device manufacturers, as part of their business strategy,
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