Cell Phones vs. Pacemakers & ICDs | Study supports risk of magnetic interference

A study published in August 2021 provided further evidence of a potential risk that some cell phones and smart watches produce enough magnetic field to interfere with implanted pacemakers. This latest study supports a notification from the FDA earlier this year about the potential risk of magnetic interference between cell phones and pacemakers.

FDA releases Guidance Document for Nitinol Devices

In July 2021, the FDA released its final version of a Guidance Document titled “Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol.” This guidance provides clear expectations from the Agency with respect to benchtop testing of medical devices which incorporate nitinol features.

How Long Does a 510(k) Approval Actually Take? 2021 edition

We ran the numbers, thanks to the availability of data from open.fda.gov. The FDA has a goal of providing 510(k) decisions within 90 “FDA days.” FDA days are the number of calendar days between the date the 510(k) was received and the date of final decision, excluding the days the submission was on hold for an Additional Information (AI) request.

3 Tips for Medical Device SBIR Grant Budgets

SBIR grants are an excellent way to generate non-dilutive funding for early stage medical device startups and entrepreneurs looking to develop an idea into a product. The National Institutes of Health (NIH) and the National Science Foundation (NSF) are two organizations which accept SBIR grant applications throughout the year and are frequent vehicles for early stage funding.

Top 3 common Biocompatibility testing pitfalls for medical devices

ISO 9001 vs. ISO 13485: Similarities and Differences

In the realm of quality management, ISO 9001 and ISO 13485 stand as prominent standards guiding organizations towards excellence. While both aim to establish a robust quality management system (QMS), they cater to different sectors and have distinct requirements. Understanding their similarities and differences is crucial for organizations aiming to implement these standards effectively.