News and Resources
Telemedicine: How the pandemic has changed healthcare services
While telehealth technology and its use are not new, trends show some increased interest in the use of telehealth services by both healthcare professionals (HCP) and patients. Due to the COVID-19 pandemic, changes in the way that healthcare is delivered are being...
Notified Body Audits during the Pandemic: New MDCG Guidance
It should come as no surprise that the far-reaching effects of the COVID-19 pandemic include how notified bodies are conducting audits of medical device manufacturers. The European Commission’s Medical Device Coordination Group (MDCG) recently released a document...
Securing Updated and Necessary Statutory Evaluations Timely Rule
In the Trump Administration’s final days, the Department of Health and Human Services (HHS) has changed the US Food and Drug Administration’s (FDA) regulatory oversight policies. The Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule would force...
Regulatory Relief to Support Economic Recovery
On May 19, 2020, President Trump issued Executive Order No. 13924. This order instructed HHS and FDA to “review any regulatory standards that they have temporarily rescinded, suspended, modified, or waived during the public health emergency,” in order to “determine...
RAPS Euro Convergence 2020 Summary
The 2020 conference, or “convergence,” of European regulatory professionals that was originally to be held in October in Brussels instead took place virtually due to the pandemic. Even though it was conducted entirely online, the convergence covered a lot of...
ACMP Clinical and Regulatory Consulting, LLC (ACMP) is now part of MEDIcept Inc.
Ashland, MA: MEDIcept Inc., an international quality, regulatory, and clinical consulting firm focused on medical device and in-vitro diagnostics (IVD), announces the acquisition of ACMP, a US-based privately held Clinical Research Organization (CRO) that provides...
MEDIcept Inc. and Arena Solutions Announce Partnership to Improve Compliance for Medical Device Manufacturers
Ashland Massachusetts, December 4, 2020 – MEDIcept, Inc., a leading international medical device and IVD compliance consulting firm, today announced a new partnership with Arena Solutions, the leading provider of cloud-based product development solutions for high...
Person Responsible for Regulatory Compliance
As the European Union’s (EU) Medical Device Regulation (MDR) and In-Vitro Diagnostic Medical Device Regulation (IVDR) continue to evolve, one requirement is getting a lot of attention – the person responsible for regulatory compliance (PRRC). This individual (or...
Brexit and the changes to medical device regulations coming in 2021
The United Kingdom’s exit from the European Union has had far-reaching ramifications for a wide range of industries, including medical device manufacturing. If you’re a medical device firm selling – or looking to sell – into the UK, significant changes are coming in...
Risk Management Series – Part 6: Estimating Probability of Occurrence
In our last article, Part 5: Assigning Harms and Severity, we addressed the importance of doing your “homework” before attempting to assess the severity of identified hazards/harms, clearly defining the use environment and user profile being considered, and...
