Medical Device Regulatory Registration

Implant Surgical Company has an ISO 13485 : 2016 version and cGMP (US FDA) regulated production system, each pahse of production process from raw material to finish products is well documented.

Traceability, Validation & an overall excellent QMS allows us to comply with regulatory requirements effectively.

We strategically support our clients to obtain the license / accelerate the registration process with international medical device regulatory authorities convergence.

That is responsive to emerging challenges while protecting and maximizing public health and safety.