Fair market value (FMV) compensation for healthcare professionals is a cornerstone of compliance under the AdvaMed Code of Ethics. It ensures that fin...

I would definitely recommend consulting for recent graduates, assuming they approach it with intention and purpose. In industries with competitive job...

Consulting and legal services often go beyond simply offering solutions or guidance in the medical device industry. They play an important role in equ...

When drafting agreements such as NDAs, consultancy contracts, or confidentiality agreements in the medical device sector, having a balance between fos...

The shift to remote work during the COVID-19 pandemic had a massive impact on leadership behaviors and organizational structures, forcing leaders to r...

Organizational change and development extend beyond structural adjustments or operational shifts; they encompass creating a foundation for sustainable...

Organizational development (OD) serves as a critical enabler for medical device manufacturing companies to successfully integrate advanced technologie...

I've personally been involved in a CAPA after a few audit findings. First of all, audits are grueling! Any and all paperwork that has ever been docume...

I agree that risk avoidance is a foundational strategy in the manufacturing process, but it must also be complemented by mitigation efforts and risk a...

Risk management is an evolving process that extends beyond compliance with ISO 14971 and encompasses a broader integration of proactive methodologies ...

Coordinating risk evaluations with design verification and validation results to assess potential risks throughout the development process is incredib...

Great question Samiha! In my opinion, when transferring design control and standards to any contract manufacturer, especially in medical device prod...

The Design Transfer team ensures that all relevant design information is provided to production teams. They consolidate every critical detail, from ma...

There are many factors that go into deciding how to interpret these guidelines. A few that I can think of include Regulatory Strategy and Risk Toleran...

I think that the steps taken to define success criteria have been more or less clearly represented by previous responses in this discussion thread. I'...