In 2016 the Medical Device Single Audit Program (MDSAP) was initiated. Having a global approach to monitoring and...
Results for "Audit"
5 Ways Prepare for a Remote Audit
A remote audit is a way of conducting an audit without being physically present. The overall goal is to evaluate and...
5 Reasons Why Internal Auditing is Important
An internal audit program is vital for proper monitoring and assurance of products. It is also essential to...
Audit Readiness
Audits can be a stressful time for a company. Even if it is known in advance when the audit will occur getting...
FDA Clarifies The Types Of MDSAP Audits To Be Conducted In The Pandemic
The FDA released an information transmittal to the MDSAP Auditing Organizations on December 31st, 2020 providing...
MDSAP Reports for EU Surveillance Audits
The Medical Device Single Audit Program covers the compliance requirements of the USA, Brazil, Japan, Canada, and...
EU’s Clarification on Medical Device Remote Audits
The European Commission published a new guidance document that clarifies certain requirements originally outlined in...
Benefits and Challenges of Notified Body Remote Audits
Many people had to transition to a remote work environment amidst the COVID-19 pandemic, with Notified Bodies being no...
Effective Internal Audits for Medical Device Firms
Internal audits are a critical activity for every medical device firm. Not only are they mandatory per 21 CFR 820.22...
Medical Device Single Audit Program (MDSAP)
In 2012, the International Medical Device Regulators Forum (IMDRF) developed the Medical Device Single Audit Program...