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©2018 by MBC & Affiliates, Inc.

We Provide Confidence, Certainty & Control

  • Emergency Assistance

  • Regulatory Compliance

  • Regulatory Strategies

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  • Auditing

  • Monitor Compliance

  • Quality Management

December 12, 2019

This week's blog is a departure from the technical discussions regarding compliance issues.  This week we share some tips on coping with stress and getting the most out of your new year's goal setting for your staff.

Management Tips

 Helping Employees to Be Less Stressed


There are a number of reasons why employees can become stressed, including workload, lack of control over the process of decision making, inefficient time manag...

December 5, 2019

For those of you transitioning from the MDD to the new EU MDR, here’s a helpful checklist published by Europa if you haven’t seen it yet.          

Feel free to reach out if you have any questions or need help with any of line items.

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.

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