Phone:

520.665.9081

  • LinkedIn Social Icon
  • Twitter Social Icon
  • Google+ Social Icon
  • Facebook Social Icon
  • Pinterest Social Icon

©2018 by MBC & Affiliates, Inc.

We Provide Confidence, Certainty & Control

  • Emergency Assistance

  • Regulatory Compliance

  • Regulatory Strategies

  • Training

  • Auditing

  • Monitor Compliance

  • Quality Management

October 30, 2019

FDA Statement
Statement On Concerns With Medical Device Availability Due To Certain Sterilization Facility Closures
 

Hello Readers!

Last Friday, Oct 25 the FDA published the statement below.  It's important to share it with you in case you missed it.  Your business should  be aware of the possible future ramifications.


For Immediate Release:
October 25, 2019
Statement From:
Acting Commissioner of Food and Drugs - Fo...

October 21, 2019

                 

                  FDA QSR-ISO Merge -  Is it Good for You?

     Today, we continue our discussion from last week’s article around the FDA’s announcement to supplant the existing US Quality System Regulation requirements with those of ISO 13485:2016.  If...

October 10, 2019

     The US FDA made an official announcement (FDA Update in December 2018) that they intend to “supplant the existing requirements with … ISO 13485:2016.”  According to the FDA, they are taking these steps in order “to harmonize and modernize the Quality System Regulation for medical devices.”  They also stated that they are doing so to “reduce compliance and record keeping burdens on device manufactures.”  Let...

October 1, 2019

                                          Why US?


Our clients love us because we get results quickly and without drama. When you’re in a regulatory squeeze, you require fast, professional, and precise advice so you can move on wit...

September 23, 2019

Who’s in the driver’s seat of your medical device supply chain? You? The FDA? Other regulatory authorities?  Industry executives are bending over backwards to meet strict regulatory, safety, and quality system requirements, to navigate ever changing submissions processes and to avoid landing a warning letter from the FDA or handed critical observations from  other Regulators. But smart companies understand that compliance runs...

September 17, 2019

Here are 5 steps you can take to help you stay on track and focused.

September 10, 2019

This blog explores 21 CFR Part 11 and breaks down the differences between system access, audit trails, and electronic signatures.

September 3, 2019

Here's 3 tips for making sure your organization's training program will stack up to regulatory authority scrutiny.

Please reload