Regulatory & Compliance Perspectives

1. 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. 

2. 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.

3. 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.

4. Looking Beyond The Pandemic: Ensuring Data Integrity Post-COVID-19 6/4/2020

   Trials that have continued through the pandemic are now producing data, and sponsors are having to adapt analysis and reporting strategies to fit their current circumstances. Data integrity is paramount now more than ever. This article shares strategies and processes being utilized by key players in the industry and provides insight into how to best proceed in the future.

5. Are You Ready? FDA’s Transition From Computer System Validation To Computer Software Assurance 6/3/2020

   The FDA is preparing to release new guidance, "Computer Software Assurance for Manufacturing, Operations and Quality Systems Software," in late 2020. This new guidance will provide guidelines for streamlining documentation with an emphasis on critical thinking, risk management, patient and product safety, data integrity, and quality assurance.

6. The European MDR: Impetus, Impacts, And Current Status 6/3/2020

   This article explains the MDD’s shortcomings, details the MDR’s history, highlights expected transition timelines, describes the most significant changes, and discusses the anticipated impact on medical device markets. It has been updated through June 1, 2020. 

7. MDR Delay Is An Opportunity To Excel, Not An Excuse To Relax 5/25/2020

   While the MDR date of application has been delayed a year, the Regulation’s final compliance date has not changed. This article discusses general concerns medical device manufacturers should keep in mind as they adjust to the new timeline, as well as four critical MDR factors to address (or revisit) moving forward.

8. Understanding Coding Standards In Medtech Development 5/11/2020

   While the adoption of coding standards in medical device development lags behind other industries focused on functional safety, such standards’ use is progressively increasing as their value in risk mitigation and efficient product development is recognized.

9. How To Adapt To Changing Single Parcel Testing Standards 5/4/2020

   Medtech manufacturers currently following the ISTA 2A package performance testing standard may wish to consider more modern standards that allow customization of some testing criteria to better evaluate real-world conditions of their packaging and distribution environments.

10. Stand By To Stand By: Organizational Contingency Planning 4/6/2020

    The coronavirus (COVID-19) pandemic has been a wakeup call, exposing the vulnerability of the global supply chain and the lack of emphasis placed on contingency planning.