Four new medtech blogs and three new authors joined our 2018 “most read” list. Regulatory was the most popular topic, followed by electrical engineering, software, and supply chain.
- How ISO 13485:2016 section 7 changes impact your QMS The majority of changes in going from ISO 13485:2003 to ISO 13485:2016 relate to risk and documentation and the training required to competently implement them all. There is no question that ISO 13485:2016 section 7 changes will impact your Quality Management System (QMS). The two major themes in changes to the ISO 13485 standard are taking a risk based approach and documenting everything. They are also two of the core differences in section 7, “Product Realization”.
- RoHS 2 vs RoHS 3 impact on medical devices RoHS 3 – The Trilogy is Complete. The Restriction of Hazardous Substances (RoHS), has had a substantial and permanent effect on the materials that go into many of the electronic products we make. Knowing what to look for and finding good vendors with appropriate quality programs will lead to a smoother product development program and faster time to market.
- Pros and cons of two popular Ultrasound signal processing techniques There are a number of methods of demodulation in ultrasound although two ultrasound signal processing techniques are used predominately nowadays. Kenneth MacCallum, PEng, Principal Engineering Physicist at Starfish Medical offers the pros and cons of both methods and concurs they will both likely be used for the foreseeable future.
- Why an electrical isolation diagram improves your medical device design. As tempting as it is to start ordering parts and tinkering for your medical device, there are a few preliminary documents you can create to help you choose the right parts. Eventually you’ll need a design that must pass the requirements of IEC 60601-1. Drafting documents now will prompt you to ask the right questions early and hopefully solve any core technology safety related hurdles early. The documents I discuss below are in addition to the standard risk management, requirements, specification, and architecture documents.
- How to Handle Medical Device Risk Management and the change from ALARP to AFAP As part of design and development at StarFish, we undertake Risk Engagements with key Stakeholders, and create a Medical Device Risk Management file, which demonstrates that risks are controlled. This blog provides details on the Directive and Standard, examines implications for the recent changes, and explains how we handle the situation. Vincent Crabtree, PhD wrote this while a Regulatory Advisor and Project Manager at StarFish Medical.
- How to identify a Conformité Européenne mark vs a China Export mark The Conformité Européenne (CE) mark is a common sight on products in North America, and Europe. However the China Export mark and CE mark are easily confused, which is understandable because they look almost identical. This similarity is something which has been acknowledged by the EU parliament.
- How blockchain technology will change the medical device industry Blockchain technology introduces new secured measures for keeping authentic and anonymously real time personal data in decentralized manner. It can be expected that upon maturity the blockchain technology behind Bitcoin will gain the required trust and be used extensively by partners of the highly regulated healthcare ecosystems: patients, regulators, clinics, pharmacies, insurers, laboratories, technology developers etc.
- Supplier Quality Agreement or Supply Agreement? In the early stages of medical device development, it is usually sufficient to secure pre- production quantities through a simplified procurement cycle. A specification, a quote, a purchase order and a certificate of conformance —what other paperwork is needed? Why clutter up a simple, well defined process with other documents and paperwork?
- How ISO 13485:2016 changes will impact your QMS (sections 4-6)With the March 1, 2016 release of ISO 13485:2016, medical device developers and manufacturers have been given a three year grace period to implement changes from the previous 2003 version. During those three years both the 2016 and 2003 versions will be valid to operate under; however after the three year grace period, compliance with the 2016 version will be mandatory. So what are the major changes and how are organizations to address them?
- An electrical engineer’s overview of IEC 60601-1 Terminology & Definitions through Annexes Part 2 of Bjarne Hansen’s Electrical Engineer’s overview of one of the more important standards for medical devices: IEC 60601-1. IEC 60601-1 is not just an electrical safety standard. At StarFish we use several checklists and templates to ensure we address all of its comprehensive requirements.
Astero StarFish is the attributed author of StarFish Medical team blogs. We value teamwork and collaborate on all of our medical device development projects.