New Guidance on Product Family Adoption for Radiation Sterilization: TIR 35:2016
Product family grouping, as discussed in Clause 4 of ANSI/AAMI/ISO 11137-2:2013, titled ‘Sterilization of Health Care Products...
Browse Content
Performance Qualification for Gamma Irradiators
Sterilization validation is a critical phase in the lifecycle of sterile products. This webinar will focus on...
Satisfying ISO 18562 and FDA Biocompatibility Regulatory Requirements for Breathing Gas Pathways in Health Care Application
In March 2017, the new ISO 18562 standard series was released, comprising four parts that address the...
Packaging Design for Sterilization
Bringing a medical device from conception to market involves numerous critical steps, one of which is often...
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...
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...