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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...
ISO 13485

ISO 13485

Achieve ISO 13485 Certification ISO 13485 is a Quality Management System standard designed for medical device companies. Being ISO 13485 compliant shows a commitment to the safety and quality of your medical devices. Documented compliance to an ISO Standard, even in...
IEC 62304

IEC 62304

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...
IEC 60601-1

IEC 60601-1

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...
21 CFR Part 820

21 CFR Part 820

FDA 21 CFR Part 820 Compliance Solutions Medical device manufacturers must establish quality systems and design controls to ensure their products meet applicable requirements and do not pose unacceptable risk to the consumer or public. FDA 21 CFR Part 820 is the...
21 CFR Part 11

21 CFR Part 11

Meet 21 CFR Part 11 Requirements The FDA requires life science companies to implement controls on the systems used to manage electronic records that are required by predicate rules or submitted to the FDA. MethodSense’s regulatory professionals are here to help you...
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...
good manufacturing processes

good manufacturing processes

21 CFR Part 820 – Good Manufacturing Processes for Medical Devices If you manufacture a medical device, the FDA will require that your quality system meet the Quality Management System Regulations of 21 CFR Part 820, which outlines the current Good Manufacturing...
iso compliance

iso compliance

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...