Hopefully, the answer is yes. May 26th, 2021 is only a matter of months away and time is short.
Please remember Advena Ltd is well placed to help those clients who do not have the necessary resources, either internally or local to their operation. We have a team of consultants, based in our offices both in the UK and Malta with a wide range of experience across the whole platform of device classifications.
Whether you need a new technical file creating or an analysis of your existing documentation and what must be done to upgrade to the MDR, we have a service that can help.
If you just need certain sections of your documentation creating or reviewing, such as Risk Management or the critically important Clinical Evaluation Report section, we can also help, or perhaps with another sections of your technical files.
Remember, you will also need to update device labelling, packaging, IFU’s etc. and while EUDAMED is not fully operational, applicable devices must be registered the competent authority where your Authorised Representative is based, there is so much to do in these remaining few months, do not delay, get in touch if you need assistance.
For further details and a quotation, Email us at: email@example.com