Day

October 2, 2018
Datascope Corporation Product: drug manufacturing facility Date:9/11/18 Purchasing controls; complaint investigations 1. Failure to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). Specifically, your firm performed a supplier assessment from (b)(4) for Circulatory Technology and approved (“(b)(4)”) the use of...
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Email: Industry.Biologics@fda.hhs.gov Phone: 240-402-8020 or 1-800-835-4709 After hours (after 4:30 pm EST weekdays, all day on weekends, and federal holidays) FDA Emergency Call Center, Phone: 866-300-4374 or 301-796-8240 What The MATTB Does CBER’s Manufacturers Assistance and Technical Training Branch (MATTB) responds to public inquiries for information (by phone and email) from the biologics industry. MATTB strives to provide...
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Quality in 510(k) “Quik” Review Program Pilot The Quality in 510(k) (“Quik”) Review Program provides an alternate method to submit a premarket notification (510(k)) to the FDA using the eSubmitter software to format the submission. The FDA has identified a list of product codes that are eligible for this pilot. These device types are moderate risk and are considered...
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Upcoming SoftwareCPR Training Courses:

Public Course – Jan 9-11, 2023 – Risk Management (in-person)

Our newly updated ISO 14971:2019 Medical Device Risk Management, A Software Organization’s Perspective public training course is now open for registration!

Where:  Tampa, Florida

  • Coverage of ISO 14971:2019, IEC 62304; amd1, and IEC/TR 80002-1.
  • System level hazards analysis – mapping to software, cybersecurity, and usability
  • Why FMEA is incomplete for medical device risk management.
  • How to perform software hazards analysis.
  • And more!

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructors: Dr. Peter Rech, Brian Pate

Discount Registration through October 31, 2022.  Reserve your spot!

Register here: https://events.eventzilla.net/e/2023-softwarecpr-public-training-course–iso-14971-medical-device-risk-management-a-software-organizations-perspective-2138576610

 

Public Course – Dec 12-15, 2022 – Being Agile & Yet Compliant (virtual)

COST: 4 half days for $1,920 per person

HOURS: 11 am until 3 pm EDT each day

TRAINING LOCATION: Virtual – live online

Register here:

https://events.eventzilla.net/e/december-2022-softwarecpr-agile-and-compliant-training-course-2138573767

 

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