Medical Devices: Regulatory, Clinical Trial and QA & Compliance Services
Aptiv Solutions is the leading medical device CRO and consulting firm, focused on delivering strategic regulatory planning and support, FDA and international regulatory submissions, global clinical trial design and execution, and unmatched quality assurance and compliance services to address FDA QSR and ISO 13485.
With an integrated approach and in-house medical device professionals, we are perfectly positioned to help clients respond to the increased rigor demanded by worldwide regulatory agencies for medical device development, approvals and ongoing compliance.
We have helped clients conduct hundreds of successful clinical trials and maintain compliance for medical devices, in vitro diagnostics and combination products in the US, Europe and around the world. Our regulatory approval record speaks for itself and is unmatched in the industry with more than 600 510(k) clearances, 50 PMA approvals, and dozens of technical files and design dossiers to obtain the CE Mark.
Our medical device submission and clinical trial experience span almost every therapeutic area and medical device specialty area, for both U.S. and international clients, with specific expertise in the following areas:
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
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
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
Medical Device Expertise
- Anesthesia and Respiratory
- IVDs / Companion Diagnostics
- Diabetes Management
- Wound Care / Wound Healing
- Radiology and Imaging
- Drug Delivery
- Tissue Regeneration / Biologics
- General Surgical
- Medical Device Software
- Consumer / OTC Products
Aptiv Solutions is a full-service consulting firm and contract research organization (CRO) that helps emerging and established firms develop and commercialize novel and innovative medical devices, in vitro diagnostics, biopharmaceuticals and combination products. Clients trust us 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.
Aptiv Solutions has helped hundreds of clients conduct successful medical device clinical trials, achieve regulatory clearance and approval, and maintain compliance for products in the U.S. and internationally, including meeting FDA submission requirements like IDE Applications, PMA Applications, IND Applications, and 513g Requests, CE Mark requirements, and Health Canada requirements. By leveraging our comprehensive knowledge of FDA and international regulations, medical device clients capture and grow market share, increase productivity, and stay competitive in an increasingly complex global marketplace.
Aptiv Solutions 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.