May 14, 2015 | Regulatory Roadmap, Risk Management
Achieve ISO 14971 Certification ISO 14971 specifies a process for medical device manufacturers to identify the hazards, or risks, that are associated with their products and to create the necessary controls to monitor them. Understanding this regulation is also... 
May 14, 2015 | Risk Management
Meet SDLC Requirements If your medical device has software that regulates its functionality in a way that contributes to Basic Safety or Essential Performance, then you will need to comply with IEC 62304. The standard requires all aspects of the software development... 
May 14, 2015 | Human Factors, Risk Management
Organize your Risk Management Program For those who design or manufacture electromedical equipment, IEC 60601-1 3rd Edition A1 is one of the most important safety and performance standards to meet. The standard addresses critical safety issues, including the risk of... 
May 14, 2015 | QMS, Risk Management
ISO Compliance for Medical Device Companies ISO compliance for medical device companies demonstrates that International Organization for Standardization (ISO) guidelines are followed. Global commercialization of your medical device most often requires ISO 13485... 
May 14, 2015 | Regulatory Roadmap, Risk Management
Regulatory Affairs Consulting Regulatory requirements impact your products – and your business – throughout their entire lifecycle. Especially when you consider that regulations are constantly changing. A single regulatory misstep or misunderstanding may stand between... 
May 14, 2015 | Risk Management
Life Science Safety Testing Management When it comes to understanding safety testing and certification, we helped write the book… literally. Rita King, our CEO, participated in the development of safety critical software standards for UL and ANSI, giving us key...