Expertise

Type of Device

Companies We Serve

Services

Choose your company

Medical Device Consultants Inc. has helped hundreds of medical device and diagnostics innovators to navigate the challenging journey from product concept to commercialization.

Services

Regulatory Services

Customer Testimonial: "Our 510(k) submission was completed in such a way that the FDA did not have any additional questions and we received clearance very swiftly."
- European medical technology manufacturer focused on thoracic surgery products

CRO/Clinical Trial Services

Customer Testimonial: "I am impressed by your speed, thoroughness, and professionalism. Thank you for all your help in making this clinical trial an enjoyable experience."
- U.S. IVD manufacturer developing automated diagnostic instruments and assays

Quality + Compliance

Customer Testimonial: "We received great feedback from our audit and were able to bring our quality system into compliance, which allowed us to receive our ISO 13485 certification."
- U.S. medical device firm developing novel drug eluting technology

Methodology

Guiding You Through the Medical Device Lifecycle

Medical Device Regulatory Compliance Process

Contact Us

Massachusetts - Headquarters

Tel: 508-643-0434

California

Tel: 858-753-1961

United Kingdom

Tel: +44 (0) 1293 429608

MDCI is a full-service consulting firm and contract research organization (CRO) that helps emerging and established firms commercialize novel and innovative medical devices, in vitro diagnostics, and combination products. Clients trust MDCI to deliver customized strategic guidance and creative "hands-on" solutions to address their unique regulatory, clinical trial, and quality assurance challenges at every stage of the medical device product lifecycle.

MDCI has helped hundreds of clients conduct successful clinical trials, achieve regulatory clearance and approval, and maintain compliance for products in the U.S. and internationally, including meeting FDA submission requirements, CE Mark requirements, and Health Canada requirements. By leveraging our comprehensive knowledge of FDA and international regulations, clients capture and grow market share, increase productivity, and stay competitive in an increasingly complex global marketplace.

MDCI has therapeutic expertise in a variety of areas including: Cardiovascular device expertise, Anesthesia and Respiratory device expertise, Bio and Tissue Engineering device expertise, Blood Bank device expertise, Dental device expertise, Diabetes Management device expertise, In Vitro Diagnostics device expertise, Infection Control device expertise, Orthopedics device expertise, and Wound Care and Wound Healing device expertise