Notified Body Opinion
Creating a documentation package for a notified body opinion can be a challenge for healthcare innovators used to working within the Pharma, Diagnostic and MedTech industries.
New documentation requirements to combination products, driven by the introduction of the European MDR legislation, has made it necessary for healthcare companies to expand their documentation beyond the drug to cover the medical device as well.
The process of creating the required documentation for both when submitting for a notified body opinion is essential for Pharma, Diagnostic and MedTech companies to get in control of. With many years of Regulatory Affairs experience from projects in the healthcare industry, our specialists can help your organization bridge the gap between drug and device.
