QMR Email Formats

Medical Equipment Manufacturing • Fallbrook, California, United States • 1-10 Employees

Key Contact at QMR

Rik Renmans

Owner

Company overview

Headquarters	1010 Quail Creek Road, Fallbrook, CA 92028, US
Phone number	+14807054009
Website	qmr-llc.com
NAICS	3391
SIC	874
Keywords	Training, Stategy, 483 And Warning Letter Responses, 510(K) Submissions And Classification Assessments, Audits And Capas, Process And It Infrastructure, Qms Implementations, Software And Gxp Information Systems, Validations - Design
Founded	2000
Employees	1-10

About QMR

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.