Our Focus Areas

Regulatory Affairs

Quality Systems and Compliance

Clinical Trials with Device Support

Global Health

How can we help your company?

Consulting Support for Medical Device and Diagnostic Companies

MedEdge is a boutique consulting firm offering customized services to medical device, diagnostic, and pharmaceutical companies.

Our niche includes helping start-ups to medium growth organizations with new technologies who are eager to get to market. We understand that time is money, so we provide guidance and resources to obtain high quality objectives in an efficient manner to reduce time to market while maintaining safety and regulatory compliance.

Overall, we specialize in quality, clinical, and regulatory consulting services for medical device and diagnostic companies. We also assist companies with regulatory strategies, review and provide input into test strategies to support market applications in the US, Europe, and global market. We can write and submit pre-market applications to respective regulatory bodies, manage the review process, and provide compliance to support commercialization.

We are proud to have partnered with over 50 companies in the last 10 years to complete clinical trials, obtain ISO certification, and gain US, European, and global commercial clearance for products.

Our Team Works with You

Our team of consultants works with you throughout the process based on their areas of expertise. This comprehensive approach ensures efficiency and the right subject matter expert for your needs. In addition, we can serve as your in-house quality and regulatory manager, including as your Management Representative.

We will work with you to determine the best solutions for your needs.

Learn More

OUR FOCUS AREAS

Regulatory Affairs

US FDA Pre-Submissions, Breakthrough Device Designations, 510(K) Applications, De Novo Applications, and 513(G) Submissions
EU MDD to MDR Transition, New MDR Applications
UKCA Applications
Australia TGA
The Americas (Canada, Mexico, Brazil, and others)
Other Global Markets

Quality Systems and Compliance

Ready-to-Use Electronic Cloud-based Quality Management Systems
ISO 13485
MDSAP
ISO 9001
ISO 17025
All supporting ISO standards for product testing (i.e. risk management, sterilization, biocompatibility, packaging, shelf life, electrical safety, software, and human factors)

Clinical Trials with Device Support

IDE Studies
Post-Market Surveillance Studies
Non-Significant Risk Studies

Global Health

Clinical Studies in Global Markets
Medical Device Manufacturing

Our Focus Areas

At MedEdge, we understand that time is money. That’s why we provide guidance and resources to obtain high quality objectives in an efficient manner to reduce time to market while maintaining safety and regulatory compliance.