November 24, 2025 MDSAP QMS Internal Auditing Must Verify Regulatory Compliance If an organization performs internal auditing only to its SOPs but not also to check the SOPs’ and the organization’s regulatory compliance, then it would be in violation of MDSAP’s requirements for internal auditing. Such an approach would, upon discovery, result in […]
<h1 class="entry-title">Category: Certification</h1>
“Declaration of Conformity” vs. “Certification of Conformity”
April 24, 2023 “Declaration of Conformity” vs. “Certification of Conformity” There are different kinds of declarations and certifications germane to the medical devices sector. And there is a proper distinction to be made between “declaration” and “certification”. I give my further interpretations about that herein. Ultimately, the precise context of each given scenario […]