The Importance of Artwork Version Control in Achieving Medical Device Regulatory Compliance
Ensuring Accurate and Compliant Medical Device Artwork
Artwork version control plays a critical role in maintaining medical device regulatory compliance. Labels, packaging, instructions for use (IFUs), symbols, warnings, and product information must remain accurate, consistent, and aligned with approved regulatory requirements.
EDQM Regulatory Update PA/PH/CEP (14) 06, 2R: Guidance on Using an Intermediate CEP in a Final Substance CEP Application
The revised EDQM Regulatory Update PA/PH/CEP (14) 06, 2R guideline clarifies how a valid Certificate of Suitability (CEP) for an intermediate (CEP X) can support a CEP application for a final substance (CEP Y).
The Strategic Importance of Usability Testing in Medical Device Development and Regulatory Compliance
Understanding the Importance of Usability Testing
Usability testing for medical devices is an integral part of developing devices, ensuring safety, efficiency, and practicality of the product in use. Testing is used to find out how users interact with the device and what challenges may arise during the use of the device.
The Role of Market Intelligence in Advancing Medical Device Growth and Innovation
Understanding the Medical Device Market
Medical device market intelligence plays a vital role in helping manufacturers understand evolving market conditions, customer expectations, competitor strategies, and regulatory developments.
What Is Regulatory Inspection?
Regulatory inspection is an official study that is performed by a government or some regulation entity in order to check the good compliance of the pharmaceutical company, laboratory, manufacturing enterprise, or any other regulated institution with rules, laws, and quality requirements.