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ISO 14971

ISO 14971

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...
FDA clearance

FDA clearance

Obtain FDA Clearance for Medical Devices The path to medical device commercialization and FDA clearance is determined by many factors. Usually this means filing 510(k) pre-market notification with the FDA. However, in some instances, it might mean taking a PMA or de...
regulatory affairs

regulatory affairs

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...
regulations

regulations

Satisfy Quality & Regulatory Requirements Determining this safety is often rigorous, time consuming and document heavy. MethodSense’s combination of software and consulting experience pairs to position your life science product and business operations to...