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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...
technology validation

technology validation

Technology Validation for Medical Devices Medical device commercialization increasingly incorporates technology solutions subject to FDA review involving standards testing, technology validation and software validation. Regulators are putting added pressure on medical...
technology management

technology management

Life Science Technology Management There is heightening pressure on life science companies to demonstrate that their technologies perform as intended and that all risks are mitigated or justified. With health care products incorporating more and more software...