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.
OUR FOCUS AREAS
Regulatory Affairs
Quality Systems and Compliance
Quality Systems and Compliance
- 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
Quality Systems and Compliance
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
Clinical Trials with Device Support
Clinical Trials with Device Support
- IDE Studies
- Post-Market Surveillance Studies
- Non-Significant Risk Studies
Global Health
Clinical Trials with Device Support
Clinical Trials with Device Support
- Clinical Studies in Global Markets
- Medical Device Manufacturing
Experience by Treatment Area
Our team of consultants brings years of experience based on their areas of expertise. Using this comprehensive approach ensures efficiency and the right subject matter expert for your needs.
- Cardiology / Cardiac Surgery
- Gastroenterology
- Obstetrics / Gynecology
- Neurology
- Orthopedics
- Emergency Medicine / Wound Care
- General Hospital / Surgery
- Wearable Devices
- Robotic- / Software-driven Medical Devices
Regulatory Experience
The regulatory experience at MedEdge encompasses everything from writing and managing pre-market FDA applications to European CE Mark, Asia, Middle East, and Africa. In the United States we specialize in FDA 510(k) applications and have received clearance for over 20 different new technologies and numerous applications for change to existing products (Special 510k). We have also obtained Breakthrough Device designation for several new technologies and have launched clinical trials to support these applications.
Globally, we have obtained market clearance for numerous products in Europe, the UK, Canada, Mexico, South America, Australia, the Middle East, Japan, and other Asian markets.
Technical Expertise
In this ever-changing regulatory environment MedEdge has stayed on top of the newest technical standards, regulations, and FDA guidance documents. We have a proven track record in managing clinical and regulatory requirements for the latest medical technologies, incorporating advanced electronics, software, Bluetooth, biodegradable polymers, and bioassays. Below are Technical Standards and Guidance Documents we can assist you with*:
- ISO 10993 series
- IEC 60601 series
- IEC 62304
- IEC 62366
- ISO 13485
- ISO 14971
- FDA Guidance – Cybersecurity
- FDA Guidance – Pre-Submission Process
- FDA Breakthrough Device Determination
- Medical Device Regulation (MDR)
*Please note this is not a comprehensive list