USA: Medical Device QMS soon harmonized
The FDA has declared its intention to harmonize and modernize 21CFR 820, the regulation of the Quality Management System (QMS) related [...]
03 07 2018
03 07 2018
12 06 2018
12 06 2018
GAMP 5 – The risk-based approach validation of GxP computerized systems
GAMP 5, the latest guideline issued in February 2018 by the ISPE (International Society for Pharmaceutical Engineering) represents the most recent [...]
10 04 2018
10 04 2018
EUROPE: comparison between the role and responsibilities of the Authorized Representative according to Directive 93/42/EEC and the role outlined in the MDR 2017/745 and IVDR 2017/746
Regulations relating to Medical Devices (MDR) and in-vitro diagnostic Medical Devices (IVDR), adopted on April 5, 2017, were published in the [...]
02 10 2017
02 10 2017
CANADA: are you ready for the MDSAP?
As of January 1, 2019, according to the Canadian classification system, Class II, III, and IV Medical Devices manufacturers who intend [...]
03 08 2017
03 08 2017
About the 60601-1-2
Electromedical device manufacturers have been dealing for some time with issues related to the electromagnetic compatibility of electromedical equipment and systems, [...]
21 07 2017
21 07 2017
Strategy and quality: a glimpse at the future
Deciding to adopt a quality system in a company can be definitely considered as a strategic choice. It is a strategic [...]
20 07 2017
20 07 2017
USA: on line the cybersecurity guideline
FDA commitment to regulate cybersecurity continues. The guideline draft “Content of Postmarket Submissions for Management of Cybersecurity in Medical Devices”, in [...]
19 07 2017
19 07 2017
How to avoid the commercialization of Medical Devices strategically (and tragically) at random
Frequently, in the firms despite heavy investments, significant timeframes, relevant costs, and frantically resources spent, to enter in a target market, [...]
19 07 2017
19 07 2017
CANADA: ready the Drug and Health product inspections database
Starting from January 2016, Health Canada published information about the inspections already executed by pharmaceutical and medical device industries until now. [...]
18 07 2017
18 07 2017
CANADA: three changes not to be missed
Health Canada, the Canadian authority that deals with Medical Devices, has recently made some significant changes to the regulatory system. In [...]
