I have just returned from a meeting in Washington where I was fortunate enough to be invited to attend a working group on Cyber Security Standard for Connected Diabetes Devices. Dr. David Klonoff of the Diabetes Technology Society is putting together a consensus standard for cyber security. As developers of medical devices, how do we […]
Before StarFish, I was a founder of a company which successfully developed, performed clinical trials and CE marked a medical device. This took a long time; much longer than I expected when I left my cushy university job and went full time with the fledgling company to hopefully flip and make millions. The reason for […]
While 510(k) is the preferred regulatory strategy of many North American medical device companies, launching in Europe first with a CE mark can be beneficial. This blog concludes my highlights of 510(k) and CE Marking similarities and differences. Last week I covered Terminology, Device Risk Classification, and Process. This week I explore the Quality Management System […]
The regulatory strategy of North American medical device companies is usually well defined – Section 510(k) of the Food, Drug and Cosmetic Act from the Food and Drug Administration (FDA) is the preferred route. However, there are instances where launching in Europe first with a European Commission (CE) mark can be beneficial (such as with a novel device), or it can simply be a […]
Validation, Cost Benefit Analysis, Vendor Quality Certification, and Version Control This is the second half of a two-part blog with injection molding partnering tips and considerations I have discovered and developed over many medical device projects for StarFish Medical and other organizations. The first blog covered basics including terminology, process, and volume. This blog will delve into financials […]
Terminology, Process, Volumes, and Time Selecting the right injection molding partner is crucial for a successful project. The costs and timescales can be a significant part of a project budget. My two-part blog provides tips and considerations I have discovered and developed over many projects at StarFish Medical and other organizations. This blog will cover basics and part […]
Earlier this year (Feb) the International Electrotechnical Commission IEC) released the IEC60601-1-2 (2014) 4th Edition standard, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.
Several new and final FDA Guidance Documents were issued for Medical Devices in the past month. Why so many?
Lord Rutherford famously said “If your experiment needs statistics, you ought to have done a better experiment”. In reality, when developing In-vitro Diagnostic Devices, and diagnostic devices in general, an algorithm is almost always required to convert the stream of electronic sensor data into a clinical relevant parameter – displaying volts or ADC counts is not […]
Mark Twain may not have been thinking of Increasing IVD Regulatory Success when he said “There are lies, damned lies and statistics” but… When developing In-vitro Diagnostic Devices, and diagnostic devices in general, a statistical algorithm is almost always required to convert the stream of electronic sensor data into a clinical relevant parameter – displaying […]
Transfer to manufacturing is sometimes overlooked during the medical device product development program. The FDA 21 CFR 820.30 requires manufacturers establish and maintain procedures to ensure that the device design is correctly translated into production specifications, and ISO13485 (required for Health Canada and Europe) requires transfer activities to be planned under section 7.3.1. You can […]
Many In-Vitro diagnostic Devices (IVDs) employ optical techniques to sense. For example, labelled antibodies fluoresce when stimulated and reagents are available which, when applied to particular body fluids, change colour depending on some physiological effect. Although research tools for detecting these effects, such as ELISA, are common in the Lab, an ELISA reader is an […]