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Subscribe NewsletterPreparing a Medical Product Regulatory Requirement Plan
Product Id
:
600173
Overview: Prior to the development of or the acceptance of a contract for development of a medical product, an important step is the development of a Regulatory Requirements Plan for the product.
Whether your organization is responsible for the development and marketing of a complete device, are an OEM or are making components specific for medical devices, it is important to understand the regulatory requirements associated with this undertaking. The Regulatory Requirements Plan outlines the elements of the regulations associated with the product and also the responsibilities for implementing the requirements. Often times the complete picture for these requirements are not totally unveiled until they are past due, discovered to be unfunded, or not defined clear enough to understand who is responsible for each element. During this hour the participant will be provided with a method of documenting a complete Regulatory Requirements Plan and come away with a clear understanding of what this plan entails.
Whether your organization is responsible for the development and marketing of a complete device, are an OEM or are making components specific for medical devices, it is important to understand the regulatory requirements associated with this undertaking. The Regulatory Requirements Plan outlines the elements of the regulations associated with the product and also the responsibilities for implementing the requirements. Often times the complete picture for these requirements are not totally unveiled until they are past due, discovered to be unfunded, or not defined clear enough to understand who is responsible for each element. During this hour the participant will be provided with a method of documenting a complete Regulatory Requirements Plan and come away with a clear understanding of what this plan entails.
Areas Covered in the Session:
- Elements of a Regulatory Requirement Plan
- When is a Regulatory Requirement Plan Necessary
- Who is required to review the Regulatory Requirement Plan
- Implementing the Regulatory Requirement Plan
Who Will Benefit:
- Executive Managers
- Program Managers
- Quality System Managers
- Regulatory Personnel
- Compliance Engineers