Quality and Regulatory Solutions for Medical Device Manufacturers, Healthcare Professionals, and Software Developers
From Concept to Commercialization
Bringing great medical device ideas to life is our mission at MedTech Results (MTR). MTR provides expertise that paves the way for success in the U.S. healthcare market, by helping our Clients navigate the maze of FDA rules and regulations. MTR success stories have involved healthcare Providers, entrepreneurs, and established medical device manufacturers—working in a variety of specialties such as orthopedics, radiology, oral surgery, wound care, ophthalmology, and diagnostic products.
Quality Systems for Medical Devices
MedTech Results can help implement the Quality system controls that are required to design, produce, and distribute medical devices, per FDA requirements. MTR develops content for all parts of the Quality Mgmt System (QMS), including design documentation, risk analyses, the Device Master Record or tech file, Quality manuals, training materials, labeling, etc. MTR can also conduct Internal Audits and Management Reviews, where applicable. MTR has established many Quality mgmt systems for device manufacturers that have been audited and certified under the ISO 13485:2016 standard
