Medtronic's Pat Shrader urges Congress to reform device facility inspections process — 5 insights

Written by Adam Schrag | May 08, 2017 | Print  | Email

Medtronic Vice President for Global Regulatory Affairs Pat Shrader urged Congress to improve medical device manufacturing facility inspections, according to FierceBiotech.

Here are five things to know:

 

1. Ms. Shrader noted companies and facilities are held to different standards based on their respective locations.

 

2. She highlighted lack of notice and investigators' erratic schedules as challenges impacting companies' ability to provide required documents and materials.

 

3. Ms. Shrader advocated for bill H.R. 1736, which proposes to standardize inspection processes.

 

4. She supports risk-based inspection schedules.

 

5. Ms. Shrader testified on May 2 on behalf of the Advanced Medical Technology Association.

 

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