RQMIS logo

we integrate regulatory, clinical and quality requirements with medical product lifecycle success.

Business Consulting And Services
Amesbury, Massachusetts
Founded in 1996
11-50 employees

our vision is simple: to be the provider of choice for the development and implementation of regulatory and insurance strategy by utilizing the most efficient and effective commercialization pathway to medical product markets across the globe, including designing the quality system that brings the product to life. when these pathways demand clinical evidence to validate that a product is safe and effective, whether it is for publication, insurance reimbursement or regulatory approval, rqmis provides our customers with complete support for the entire product lifecycle. since 1996, rqmis has been providing manufacturers in the medical and healthcare industries with strategic guidance on how to effectively navigate the fda and eu regulations. our consultancy is focused primarily in four areas: regulatory strategy and submissions, clinical study design and management, quality systems design and compliance, and insurance reimbursement. our headquarters is located in boston, ma and we have two additional locations in london and barcelona.

Company Information

Industry
Business Consulting And Services
Company Type
Privately Held
Founded
1996
Employee Range
11-50
Revenue Range
Not available

Location

Address
110 haverhill road
City
Amesbury
Region
Massachusetts
Postal Code
01913
Country
United States Of America

Specialties

Medical DevicesRegulatoryClinicalConsultingQuality Management Systems510(k)Fda ClearanceEu Mdr / IvdrClinical Trial DesignEu Authorized RepresentativeUs AgentAuditsFda PresubmissionTechincal FilesClinical Evaluation Report (cer)Regulatory StrategyProduct ClassificationInsurance ReimbursementPost-market SurveillenceUk Responsible PersonDe NovoFda Consulting

Web Presence

Websiterqmis.com
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CrunchbaseView Profile

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