Brexit and UKCA Mark for Medical Devices
Due to Brexit, UK will not recognised CE mark for medical devices and an UKCA mark and the related UKCA…
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…
Change Control Process
An efficient change control process is nowadays essential for any Quality Management System within a regulated environment and both FDA…
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…
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…
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…
Device Master Record
The device master record is a design document specifically requested by the FDA Quality System Regulation, as per 21 CFR…
Design Verification vs Design Validation: What are The Differences?
Introduction to Verification vs Validation Design verification and validation are critical components of the design process when developing a medical…
FDA Requirements for UDI on Medical Devices
The UDI (Unique Device Identification) is a system used to uniquely identify medical device sold in a specific country, for…
How to write a Quality Manual fully compliant with ISO standards?
The quality manual is one of the most important documents for a company with a quality system in place, and…
