How to use ISO 13485 to comply with In Vitro Diagnostic medical devices (IVD) requirements in UK
Waqas Imam
In vitro literally refers to a test or examination outside a living organism. This happens in a laboratory or a...
In vitro literally refers to a test or examination outside a living organism. This happens in a laboratory or a vessel or any other controlled testing location. In vitro diagnostic medical devices (IVD’s) comprise of...
Medicines and Healthcare products Regulatory Agency in the UK – What does it do and how can ISO 13485 help?
The Medicines and Healthcare products Regulatory Agency (MHRA) is the United Kingdom’s governmental agency that controls and regulates blood components...
The Medicines and Healthcare products Regulatory Agency (MHRA) is the United Kingdom’s governmental agency that controls and regulates blood components for transfusions, advanced therapy medical products, medicines and medical devices throughout the United Kingdom. MHRA...
How to use ISO 13485 to get your devices approved for CE Marking
The CE marking is a gateway to marketing products in Europe, even if the medical device was produced somewhere other...
The CE marking is a gateway to marketing products in Europe, even if the medical device was produced somewhere other than the European Union. It is the producer’s mandatory obligation to acquire and display the...
Differences and similarities between FDA 21 CFR Part 820 and ISO 13485
ISO 13485:2016 is a voluntary standard for Quality Management Systems of medical device manufacturers and suppliers, and is used worldwide for...
ISO 13485:2016 is a voluntary standard for Quality Management Systems of medical device manufacturers and suppliers, and is used worldwide for developing and maintaining the system that caters to the needs of the market requirements for...
Considering human factors in Medical Device Design
Human factors are one of the most important considerations in the design of medical devices, and are reflected in an ISO...
Human factors are one of the most important considerations in the design of medical devices, and are reflected in an ISO 13485 Quality Management System as design and development inputs. Human factors to consider include the requirements...
How to use ISO 14971 to manage risks for medical devices
A patient undergoing a surgical procedure places his trust in the surgeon, the institution, and the procedure of surgery. He...
A patient undergoing a surgical procedure places his trust in the surgeon, the institution, and the procedure of surgery. He is least concerned about the medical devices, and not aware of the associated safety risks....
