51ÁÔÆæ

Medical Device Regulations Changes coming with Brexit. Listen to this highlight from 51ÁÔÆæ Radio where Seyed Khorashahi breaks down the UK’s Medical Device Regulations resulting from Brexit and choosing not...

The application date of May 26, 2022, for the EU In-Vitro Diagnostic Medical Devices Regulation (2017/746) (IVDR) has created a huge challenge for IVD medical device firms planning to introduce...

While audits are not being conducted in the same way they were before the global pandemic, they continue to take place. New procedures adopted to deal with the coronavirus outbreak...

In this soundbite from 51ÁÔÆæ Radio, Dr. Helin Raagel and Dr. Matthew Jorgensen from Nelson Labs explain biocompatibility testing. This includes the risk-based biocompatibility evaluation that medical devices go through...

Data integrity is the reliability, consistency, and accuracy of data at rest and in transit. Quality data adheres to several standards, beginning with integrity, confidentiality and availability. Data integrity is...

Whether building a new facility (greenfield) or upgrading a pharmaceutical manufacturing site (brownfield), it is important to understand the regulations governing facilities and inspection readiness. The Code of Federal Regulations...