The importance of our FDA Company Registration

In April 2017, Orthoplastics Ltd became an FDA registered organisation. But why is this important to our business and customers?

Being FDA registered means Orthoplastics comply with the practices of 21 CFR: part 820, which is the code of federal regulations for quality systems relating to medical devices.

A key difference between this and our standard quality management registration is non-compliance to 21 CFR: part 820, which breaks US Law and Regulations.

We have many US-based customers and need the surety that we can meet US market standards and expectations

As a high percentage of our customers are US-based, compliance is paramount for ensuring safe delivery of goods into the US medical device market.

Orthoplastics can provide assistance with FDA product registration as a contract manufacturer within the UK, and our quality team is on hand to provide regulatory and compliance support relating to any new or ongoing applications.

Supporting customers, wherever they are in the world

Mark Allen, Managing Director, said, “We are exceptionally focused on quality as a business. We understand that medical device specifications and products must be consistently delivered to the highest standard. Our various quality registrations prove that we are capable of achieving this and fulfilling the requirements of our customers, wherever they are in the world.”