Clinical Evaluation Requirements for Medical Device – Meeting Medical Device Clinical Evidence Requirements – CE Marking
Clinical Evaluations are mandated by the Medical Device Directive (MDD) to ensure the safety and efficacy of...
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Navigating Complexities of Name Changes and Re Registrations
Medical device manufacturers often overlook the complexities involved in changing product names or ownership, both of which...
Merger and Acquisition Re Registration: Navigating the Re Registration and other Complexities of M and A and Carve Outs
In M&A or carve-outs, pharmaceutical executives often underestimate the complexities of disentangling operations and the extensive effort...
Pharma Product Launch and Lessons Leaned Crisis Playbook: Lessons learned from Real Investigations of Product Failures
When a medical or pharmaceutical product fails in the field, the repercussions are far-reaching. Not only do...
Life Science Due Diligence Beyond the Obvious: Managing Business Risks During Life Science M and A Due Diligence
In the business press, discussions of mergers or acquisitions (M&A) invariably highlight the high percentages of deals...
The Metrics of Quality Culture
The long-awaited and anxiously anticipated FDA guidance on quality metrics was finally distributed for comment on July...