Medical device manufacturers rely on suppliers for many goods and services. Under the FDA Quality System Regulation, manufacturers hold ultimate responsibility, yet do not always enjoy the desired degree of control and accountability from their various vendors. Suppliers, particularly those unfamiliar with the regulated medical products industry, may make well-intended changes or improvements that throw finished devices out of specification, or bar access to processes or records on grounds of trade secrecy.
- What steps can manufacturers take to ensure that suppliers operate within the company's quality system requirements?
- What contractual arrangements allow access to needed documentation, and protect the manufacturer against supplier problems?
- What provisions lay the foundation for a sound and productive manufacturer-supplier relationship?
Hogan Lovells Partners Ted Wilson and Stephen Zempolich will discuss challenges and solutions for structuring contractual agreements with vendors, contractors, and consultants.
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