How to define roles and responsibilities within an ISO 13485-based QMS
Strahinja Stojanovic
Updated: August 29, 2023 When you are developing a Quality Management System (QMS), you need to assign and document the...
Updated: August 29, 2023 When you are developing a Quality Management System (QMS), you need to assign and document the roles and responsibilities within your management system. ISO 13485 highlights this need, as shown primarily...
How to perform an ISO 13485 management review
Updated: September 30, 2023 Many companies see management review as an unpleasant necessity for maintaining compliance with ISO 13485. If...
Updated: September 30, 2023 Many companies see management review as an unpleasant necessity for maintaining compliance with ISO 13485. If used properly, however, this is far from the truth. Regardless of how you organize your...
What are the consequences of noncompliance with ISO 13485 for manufacturers of medical devices?
Today’s business owners have a wide array of concerns, not the least of which is turning a profit in what...
Today’s business owners have a wide array of concerns, not the least of which is turning a profit in what can be a volatile economy. However, financial success is of little consequence if the government...
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...
