MDR: Maximizing Changes to Medical Device Reporting Regulations

Back in May, 2017, the EU Medical Device Regulation (MDR 2017/745) entered into force, replacing the existing Medical Device Directive (MDD). Since then, both the European Union and the United States have completed their 3 year transition period (May 26, 2021), by which all manufacturers should have updated their technical documentation and processes. With impacts...

Top 5 Reasons Why Training Management Must Be Part of a Medical Device Manufacturer’s QMS Implementation

Outdated training management tools and technology may be costing your firm unnecessary time and money. By automating employee training and integrating it as part of a comprehensive QMS, a medical device manufacturer can easily initiate, supervise, and finalize the training workflows from a single dashboard. This provides a single source of truth for all stakeholders, including suppliers, customers, and employees.

Top 5 Technology Trends to Prepare for in 2021

This past year is one that many would like to forget and for good reason. COVID-19 has impacted our lives in so many ways and the long-term implications are still unknown. Companies across all industries were impacted and just like when any crisis strikes – there have been those that gain and those that lose....