We are seeing an era of change by the Global regulatory bodies for Pharmaceuticals, Medical devices and in-vitro diagnostics - and companies in the Life Sciences sector are working overtime to understand and adopt this brand new world.
While the companies in the US are facing regulatory headwinds on Patient safety, the EU region is shaking the world with the new MDR and IVDR guidelines.
The overall intent is good but the journey towards bringing this change is going to disrupt a lot of companies in the way.
The main challenges for the Medical device or in-vitro diagnostics companies are:
• Accurate classification of the device based on risk to patients
• Deeper Clinical testing
• Higher role for Notified bodies
• Strong post market surveillance
Each of the above is important separately and collectively. Companies should prepare way in advance so their products stay in the market whilst the implementation of these regulations. Although some of the companies may run out of fuel since their margins will not be able to support the needs.
We at Alpha MD keep working on assisting our EU & UK clients to make their transition smooth.
Kindly contact us for any of the following:
• Clinical Evaluation according to MEDDEV 2.7/1 Rev 4
• MDR Gap analysis
• MDR Transition strategy
• MDR Transition (update technical Files -Design Dossier, quality management system)
• IVDR Gap analysis
• IVDR Transition strategy
• IVDR Transition (update technical Files, -Design Dossier, quality management system)
• Quality Management System according to EN ISO 13485:2016
• Establish Technical File / Design Dossier according to MDD or MDR
• Establish Technical File / Design Dossier according to IVDD or IVDR
• Biological Evaluation and Toxicological Evaluation according to ISO 10993-x
• Act as EU Authorized Representative
We and our partners are happy to be a shepherd and get you through this transition smoothly.
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