Should increased scrutiny be applied to the oversight of laboratory developed tests?
Why is your regulatory data stored in regional silos? Why is there a requirement for inter-departmental data requests? Why does it take 3 days, 3 weeks, 3 months to find what you are looking for? Why must the regulatory team triple check spreadsheets for data accuracy? Why are weekly registration update meetings scheduled throughout your …
The predictions of an apocalyptic melt down of the medical device industry has not (yet) come to fruition
The act of maintaining MDR compliance now represents one of the biggest challenges for Medical Device companies entering or continuing business in the European market.
Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional MDCG 2021-1 Rev.1 The objective of the guidance is to describe the harmonised administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional, anticipated for 26 May 2022. The proposed solutions aim to allow all …
The European Commission has published a very comprehensive factsheet intended to support the legal manufacturers of Class I medical devices
What does your China regulatory strategy look like?
Internal regulatory data and intelligence is an often forgotten, yet critical source of information. Every organisation’s electronic files provide a rich source of data for strategic registration planning and policy creation.
How many of you have initiated contact with someone you haven’t met (in person) as you struggled to answer a challenging internal query? During this period of lockdown and working from home, I have found myself reaching for my contact lists, both internal and external, more often than in previous months.
Regulatory change strategy may be defined as “the comprehensive elucidation of a project designed to achieve a specific regulatory goal, such as to obtain a new approval or clearance of an amendment.”