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

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

Advertisement

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.

 

More articles on devices:
Amendia, Medtronic & more: 8 device company mergers, acquisitions and agreements in April 2017

Medtronic, J&J, K2M & more: 13 device company key notes

Bone cement market to grow at 6.7% CAGR through 2021 — 3 observations

At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.

Advertisement

Next Up in Spinal Tech

Advertisement

Comments are closed.