- Value of Standards throughout the Total Product Life Cycle
- Challenges and potential ways to address the hurdles
- Overview of the Regulatory Environment and it’s Relationship with Standards
As regulations get more complex and technologies are changing at a rapid rate, it’s important to find ways to support all stakeholders to medical devices by getting your products to market quickly in a safe and effective manner. The stakeholders include OEM Technical Personnel, Clinicians (Users), Patients, and Regulators. Each of these roles brings their expertise to the table and if you don’t understand how and when to use a standard, you aren’t serving yourself and the other stakeholders.
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