A recent quarterly report by Stericycle ExpertSOLUTIONS about Q2 2016 shows a rapid increase in product recalls in a variety of markets. Recalls can be associated with a growing number of reported consumer injuries in the first two quarters of
Since 2011, medical devices have become increasingly sophisticated, and as the level of sophistication has increased, so has the time needed by the FDA to assess complex 510(k) medical device submissions (the majority of which are class 2 devices). Most
Risk management is of such vital importance in the development of medical devices that a separate standard was devised to ensure the adequacy of hazard reduction processes. ISO 14971, a standard titled Medical devices — Application of risk management to
Development teams working on safety-critical end products (such as automotive embedded products, airborne flight equipment, railway equipment, and so on) really understand the importance of quality. One small fault in the product could cause catastrophic events, and in the case
Innovation in the Medical Device Development industry is hampered by complex standards and regulations and once the medical device prototype is developed and tested, it then faces a long approval process. Traceability is essential for ensuring compliance with medical device
The medical device manufacturing industry is among the world’s fastest growing industry sectors. According to research, the majority of companies operating in this market are optimistic about the future of the industry in 2016. And for good reason: the medical electronics
The reliance on embedded software is increasing as medical devices are achieving higher and higher levels of sophistication. Despite widespread discussions of the benefits that adopting Agile could bring to software development companies, some medical device developers still hesitate to make
A lot of companies working in industries that are highly regulated by standards and guidelines (safety-critical industries, such as the medical, automotive and aviation sectors) still rely on the Waterfall/V-model development method when creating software for their end products. While
Building software to be used in safety-critical environments (for example, software embedded in medical devices, automotive or aviation systems, railway software, etc) is different to “ordinary” software development. As human lives may be dependent on these systems, it is imperative
Medical, Automotive Product Recalls Increasing in 2016
Why Medical Device Development Requires ALM Software?
Since 2011, medical devices have become increasingly sophisticated, and as the level of sophistication has increased, so has the time needed by the FDA to assess complex 510(k) medical device submissions (the majority of which are class 2 devices). Most
ISO 14971: Medical Risk Management Best Practices
Reacting to a Shifting Business Environment with Modernized Processes
Merken
Case Study: How Does the World’s Largest Medical Technology Company Use codeBeamer ALM?
Leveraging Traceability In Medical Device Development
Innovation in the Medical Device Development industry is hampered by complex standards and regulations and once the medical device prototype is developed and tested, it then faces a long approval process. Traceability is essential for ensuring compliance with medical device
2016 Trends and Challenges for Medical Technology Providers
The medical device manufacturing industry is among the world’s fastest growing industry sectors. According to research, the majority of companies operating in this market are optimistic about the future of the industry in 2016. And for good reason: the medical electronics
Agile + IEC 62304: Using Agile in Medical Device Development
The reliance on embedded software is increasing as medical devices are achieving higher and higher levels of sophistication. Despite widespread discussions of the benefits that adopting Agile could bring to software development companies, some medical device developers still hesitate to make
Adopting Agile & Maintaining Process Control in Safety-Critical Device Development
A lot of companies working in industries that are highly regulated by standards and guidelines (safety-critical industries, such as the medical, automotive and aviation sectors) still rely on the Waterfall/V-model development method when creating software for their end products. While
Safety-Critical Software Development 101
Building software to be used in safety-critical environments (for example, software embedded in medical devices, automotive or aviation systems, railway software, etc) is different to “ordinary” software development. As human lives may be dependent on these systems, it is imperative