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. 

Steel We Use:-

Based on the mechanical properties and composition, the American Iron and Steel Institute (AISI) differentiate all steel, about 80 types, After all, the wrong material choice could lead to disastrous consequences.

The most used types of steel, when making surgical instruments, are the 300 and 400 series described below .

This types of steel is rust and corrosion resistant, has good tensile strength and will provide a sharp edge for repetitive use.

The 300 series steels are manufactured from the austenic steel class and cannot be hardened by heat treatment.

400 series steels are manufactured from the martensenic steel class series and can be hardened by heat treatment.