Regulatory & Compliance Perspectives

1. How To Implement Continuous Process Monitoring Of Validated Processes 10/28/2020

   It is time to consider augmenting your validated pharmaceutical, medical device, and tissue production processes, including processing, packaging, and labeling, with continuous process monitoring to ensure continued compliance with established specifications and requirements if you do not want to be cited by the FDA.
   
    

2. ISO 14971: Harnessing Preliminary Hazard Analysis (PHA) To Develop Safer Medical Devices 10/19/2020

   Engineers tend to focus on device failures and failure modes, and their causes and effects, in order to make sure the device “works” reliably. But device failures and failure modes don’t necessarily lead to hazardous situations and harms, and harms can occur even when there is no device malfunction. This is where a preliminary hazard analysis (PHA) can help.

3. How To Improve FDA Inspection Readiness & Outcomes By Mining Publicly Available Data 10/14/2020

   Now that we have years of real-world regulatory outcomes data available, why are we ignoring their power to serve as a corrective lens for our interpretations of the law?

4. ISO’s Updated 22442 Animal Tissue Standards — What Changed? 9/29/2020

   This article provides a high-level summary of the updates to ISO 22442-1:2020 ( Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management) and ISO 22442-2:2020 (Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling).

5. Ask The Expert With Christian M. Kelly – Corporate Vice President Of Quality At B. Braun Medical Inc. 9/8/2020

   This article asks Corporate Vice President of Quality at B. Braun Medical Inc. about how quality is impacted in medical device companies by FDA regulations, collected data, and more.

6. UDI At The Point Of Use: Should You Implement Direct Marking Now? 9/7/2020

   Looking at the FDA and MDR compliance deadlines for UDI marking can be deceiving. The intense knowledge buildup, planning, and supply chain preparation efforts necessary, along with internal procedure readiness and process changes, require a long lead time.

7. Less Than A Year Until EU MDR: Are All Your “Economic Operators” Compliant? 8/20/2020

   Although the new requirements relating to economic operators under the EU MDR may still raise questions for manufacturers, the recent delay of the date of application by one year will give the industry additional time to get their regulatory matters in order.

8. Implications Of COVID-19: EU MDR Implementation Update 7/8/2020

   Learn how the EU 2020/561 Article 59 update, progress on guidance documents, formation of Expert Panels, and more affect your company. 

9. Brazil’s Medical Device Market: Patient Demographics, Healthcare System, And Outlook 6/24/2020

   Government initiatives, favorable demographic conditions, and increased patient purchasing power are among the factors that make Brazil an attractive medtech investment definition. Challenges are weighed against opportunities in this article, the second of a two-part series examining the Brazilian medtech market and factors that affect it.

10. Understanding Medical Device Regulation In Brazil 6/15/2020

    Latin America’s largest medical device market is streamlining its registration process and attempting to harmonize with globally recognized standards. Challenges are weighed against opportunities in this article, the first of a two-part series examining the Brazilian medtech market and factors that affect it.