A Guide to Medical Device Labeling Requirements

As an indispensable part of the medical device that ultimately ends up on the market, labeling is subject to FDA quality assurance requirements. These relate to the materials, operations, and controls of your labeling process, as well as the manner of application, inclusion in packaging, and other factors. To produce compliant labels, manufacturers have to manage, track, and update a significant amount of data.

The Essential Guide to ISO 14971

The International Organization for Standardization created ISO 14971 to assist medtech manufacturers in developing processes for evaluating, monitoring and controlling the risk that their products could cause harm to patients, operators, or other individuals. ISO 14971:2019 is the third and most recent edition of the standard.

The Essentials of Software as a Medical Device (SaMD)

The digital revolution and IoMT (Internet of Medical Things) has transformed the healthcare landscape. Software and connected devices are now being used to power disruptive medical technologies and solutions. Bioinformatics, point-of-care diagnostics, and 3D printing are just a few of the exponential medicine breakthroughs enabled. Software is changing how healthcare professionals act and react, how they interact with their patients, and patients' abilities to take charge and manage their health like never before.

Future Trends and Regulatory Challenges in Medical Device

Medical device manufacturers continuously try to streamline operations, improve quality, and reduce costs while struggling with global supply chain disruptions and changing regulatory requirements. 

Top 10 Medical Device Testing Companies of 2021

The medical device industry includes a wide variety of life-saving and quality-of-life-promoting tools and technologies. The range stretches from ophthalmic, orthodontic, and orthopedic devices to active implant, in-vitro diagnostics, and other breakthrough innovations. To ensure the effectiveness and safety of medical devices, national and international regulations must be complied with before these finished products and...

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 2022

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....