EVERYONE is feeling the stress of the deadline. Combine that with shriveling corporate budgets and sales driven priorities and you get a really tough situation for those in charge of putting full Tech Files together and sent off to Notified Bodies.
I strongly believe that every firm can get their devices certified under MDR when the time comes, BUT it’s going to require something that not everyone will be willing to do.
It’s going to require a new approach. Without it, deadlines will be missed, quality will suffer and CAPAs will plague teams for years to come.
Our world is CER and Literature Search. These two documents are essential in your MDR submission, and we have dedicated ourselves to them because of the incredible strain their completion can place on your team.
If you’ve ever conducted and written an Literature Search before, they are a PAIN. Running the same searches across multiple global databases, compiling the results, reviewing everything and making your assessments, and on and on…
All culminating in the drafting of a massive document including all your work, summary tables + calculations, trending data, references etc.