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What is good clinical practice (GCP)?
Good clinical practice (GCP) GCP is an international quality standard that governments can transpose into regulations that decide how clinical
AUDITING A QMS ACCORDING TO ISO 13485
When considering obtaining an ISO 13485 certificate, developing and implementing a quality management system (QMS) is not the end of the road. Indeed,
Essential documents according to ISO 14155:2020
A typical consultation we receive at AKRN Scientific Consulting is related to the essential documents required for planning, conducting and closing
AKRN joins NAMSA – world leading MedTech Contract Research Organization (CRO)
Acquisition to Enhance Cardiovascular Expertise and Regional Presence in Europe TOLEDO, OHIO and MADRID, SPAIN — MARCH 21, 2022 NAMSA, a
Performance Studies for SARS-CoV-2 IVD tests
Performance studies for SARS-CoV-2 IVD tests have become a hot topic since the publication of the MDCG 2021-21 and the common list of COVID-19 IVD
CER according to the MDR
MDR Clinical Evaluation: definitions EU Regulation 2017/745, commonly referred to as Medical Device Regulation (MDR), requires the assessment of
What You Need to Know About the New ISO 14155:2020 Standard
New requirements in the ISO 14155 standard for Medical Device Clinical Investigations The ISO 14155:2020 (Clinical investigation of medical devices
The 4 Pillars of Successful CER Writing
Writing an exemplar Clinical Evaluation Report (CER) requires skills that blend scientific, medical/clinical, regulatory, and technical competences. A
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