Combination Products and EU MDR 2017/745 Regulation
Combination products will undergo to a substantial change under the EU MDR 2017/745 and new regulatory challenges are at the horizon. Drug-device combinations (DDC) became an essential tool for
Change Control Process
An efficient change control process is nowadays essential for any Quality Management System within a regulated environment and both FDA and EU MDR 2017/745 requests particular attention to the management
MDSAP : Medical Device Single Audit Program
The MDSAP is an audit program that allows auditing organization to perform a single audit of a medical device manufacturer to obtain a certification that takes in consideration the applicable
Process Validation for Medical Devices: Overview of FDA Requirements
What is Process Validation? Medical device process validation and the related IQ/OQ/PQ technique, is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes
GAMP-5 Guidance for Computer System Validation
GAMP-5 guidance, the related "V model" and the different software categories used to simplify the validation activities are nowadays considered the internationally recognised best approach for computer system validation. GAMP
