Your Partner in Excellence
WCRO has worked with prominent general and plastic surgery manufacturers by offering proven, results-oriented development services. Our team of clinical, quality and regulatory experts have decades of experience with the complete risk-spectrum of surgical devices—from low-risk devices to complex high-risk novel devices. We have supported sponsors through all phases of product development and for a wide range of general and plastic surgery categories from conception through to commercialization.
To ensure success, we help our clients:
- Plan and conduct General & Plastic Surgery studies for device and cardiac safety and efficacy
- Discover all necessary outcomes for reimbursement using our WCRO development approval methodology
- Maintain high levels of compliance after regulatory and payer approval
WCRO can take on projects of any complexity with experience in the following areas and more:
- Diagnostic Devices
- Prosthetic Devices
- Surgical Devices
- Therapeutic Devices
WCRO General & Plastic Surgery Device Case Studies
Frequently Asked Questions
What is the difference between a cosmetic and a medical device?
Medical devices are intended to diagnose or treat a medical condition or affect the structure or function of the body. Cosmetics are not subjective to the same regulations as medical devices. The FDA regulates false eyelashes and artificial nails as cosmetic, though they are under the Consumer Product Safety Commission’s jurisdiction. It is crucial to have an experience professional, like WCRO, help make the distinction.
Does my surgical device need FDA approval—it isn’t a scalpel!?
It all depends on the risk of your surgical device. While the answer may seem clear, it is important to consult an expert team before marketing. WCRO can help determine whether your device is exempt or, in the event it is not, what level of risk and class the device falls under and how to proceed forward.
What do I do when another product similar to ours is recalled?
We hate to do this to you again: but it depends. Consulting an experience professional should be your first step. If you do not have one on your team, consulting with a CRO is best. At WCRO we routinely assist medical devices to
determine next best steps when warning letters have been issued or when there you have questions about what it means for your device when someone else gets one.