Medical Device and Combination Products

Patients are waiting for your medical innovations. Let us help accelerate your pathway to approval.

Thanks to advances in drug delivery technology, the number of approved medical devices and drug device combination products (which consist of an active pharmaceutical ingredient and a medical device) are expected to grow significantly over the coming years.

Extensive experience to accelerate approval

Cardinal Health Regulatory Sciences offers a comprehensive range of services to developers of medical devices and combination products, from clinical research through post approval. We have supported devices and combination products across 13 of the top therapeutic areas. Our services are designed to serve both smaller companies that need an experienced partner to navigate the regulatory process, and larger companies that need support to augment an existing team.

Our services for developers of medical devices and combination products include

  • U.S. Facility Registrations and US Product Listings
  • Application preparation and submission, including advisory board meetings, 510(k)s, PMAs, IDEs, 513(g)s, and technical files for CE Mark
  • Remediation, recalls, corrections and removals
  • Design of experiments, human factors engineering, design/process validation and risk management
  • QMS development and implementation (including ISO 13485:2016 preparation and gap analysis)
  • Global combination product regulatory strategies, classification and approval pathways
  • Combination product quality system development and implementation, across multiple facilities
  • Manufacturing transfers and change control assessments

Discover how we can help you.

Our regulatory experts have deep experience in accelerating approval for innovative med devices and combination products. Contact us today.

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