“Unachievable Deadlines” – The EU’s Team-NB Calls for New Guidance on Allowing Remote Audits
Author: Stacie Beecham Resource constraints facing global manufacturers are also being felt by Notified Bodies (NBs) across Europe, due to the additional requirements imposed by the new MDR/IVDR Regulations. Team-NB, […]
9 Tips To Ace The MDSAP The First Time
Author: Suzanne Broussard Take the advice of industry experts and AOs—the key to acing the MDSAP audit is to prepare, prepare, prepare. The MDSAP audit process is intense in that […]
What To Expect During An MDSAP Audit
Author: Suzanne Broussard Risk Assessment is the Cornerstone of the MDSAP Audit When preparing for the MDSAP audit, it is important to understand that the audit focuses heavily on risk-based […]
