Getting marketing clearance for your medical device can be a great challenge, especially without the assistance of an established expert. Having to coordinate with myriad regulatory agencies—each with its own requirements, regulations, and guidance—can make approval a lengthy process.
Working with a team that has traveled this road before can significantly improve your chances of success. That’s why Busse Hospital Disposables offers medical device companies the following services to expedite the regulatory process:
US Regulatory Services
- Pre-market notification — 510(k)
- Combination product (drug/device) submissions
- Establishment registration and device listing
- US Agent
Canadian Regulatory Services
- Medical device license applications (Class II and III)
- Medical Convenience Kit tray
- Medical Device Establishment Licenses