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....
How to use ISO 13485 to fulfill FDA regulatory classes for medical devices
As a medical device manufacturer, even if you don’t have the ISO 13485 certification, you have to comply with the applicable...
As a medical device manufacturer, even if you don’t have the ISO 13485 certification, you have to comply with the applicable regulatory requirements to market your products. Compliance with regulatory requirements is given equal importance in...
Using ISO 13485 to manage process validation in the medical device manufacturing industry
During manufacturing, a medical device is either in the final stage of manufacturing (finished goods) or in the semi-finished goods...
During manufacturing, a medical device is either in the final stage of manufacturing (finished goods) or in the semi-finished goods stage. Industrial processes in medical device manufacturing facilities convert raw materials into semi-finished materials, and...