QMR, LLC

Medical device quality assurance and regulatory affair consulting services. Expertise in quality assurance and management and medical device regulatory affairs. Other areas of proficiency include all FDA regulations, ISO 9000/13485 international quality standards, sterilization, product safety and liability, SEI Capability Maturity Model, and client satisfaction. Expertise in a wide range of products, including IVD, biologics, pharmaceuticals, software, medical device data systems, mobile medical applications, instrumentation, electronics and disposables. Effectively implemented and maintained compliance with regulations and standards through training and awareness initiatives. Utilized team building programs and strong working relations with the FDA and standards and industry associations.

Company’s Keywords:

software & gxp information systems, 510 submissions & classification assessments, 483 & warning letter responses, qms implementations, audits & capas, training, validations design, process & it infrastructure, stategy