Are You Prepared for the FDA’s New Regulations on MedTech Manufacturing?

Did you know we’re the first staffing company to be ISO 13485 certified? That means we’re able to provide purpose-built solutions for FDA regulated medical device manufacturers.

The 2016 revision to the standard was developed to further harmonize it with the FDA Quality Systems Regulations for Medical Devices. The grace period for this new revision ends on February 28, 2019—not too far away!

So what does this mean for medical device companies?

One of the primary focuses of the new revision is to put added responsibility on the company/buyer in terms of risk management.  The certified companies must show evidence of risk management as it relates to the requirements of the customer (or the patient).  One of the key areas of risk management focus is supplier management. And that is because there is often too little oversight or control of suppliers to medical device companies.

The message is that companies must demonstrate supplier management policies, practices or requirements that minimize the risk.  

In addition, the FDA is soon going to expect more controls in quality management principles for service providers to MedTech companies, as referenced in a recent report from the FDA.

This is consistent with earlier FDA clarifications of the cGMP’s as it relates to services. An excerpt from the FDA and Worldwide Quality Systems Requirements Guidebook: “First, as used in the regulation, ‘service’ means parts of the manufacturing or quality system that are contracted to others, for example, plating of metals, testing, and sterilizing, among others. Second, FDA believes that all suppliers of such services must be assessed and evaluated, just like a supplier of a product.”

Temporary staffing service providers place workers in companies that design, fabricate, assemble, inspect, test, label, package, distribute and service products—the potential risk is clear. And there is no better evidence of compliance to your Quality Management System (QMS) requirements than to use providers that have also been ISO 13485 certified for products or services.  Without certification, the buyer may need to do additional assessment or audits of the supplier.

With Eastridge Workforce Solutions - MedTech Division and its ISO 13485 certification, your company is compliant, your cost of compliance is lower, and you are in good hands!