QMS Compliance for Startup Medical Device Companies

Implementing and maintaining a quality management system (QMS) is a crucial part of regulatory compliance for most markets worldwide.

For small medical device manufacturers in the pre-production phase, an initial implementation of a partial quality system is an extremely beneficial way to ensure compliance with product development regulations, such as Design Controls.

Pre-production QMS for eventual compliance with FDA QSR and ISO 13485

While a quality system typically does not have to be fully implemented until you begin your medical device registration, implementing an initial partial QMS system can make implementing a full QMS less burdensome, and may shorten your time to commercialization in the long run.

A pre-production QMS is ideal for medical device manufacturers that are 18-24 months away from commercialization and distribution.  The benefit for this approach is to allow the organization to build and improve their quality system as they proceed through design and development, validation testing, conducting clinical trials, and eventually market launch.

Compliance with design control procedures

The US Food and Drug Administration (FDA) and other market regulators require proof of compliance with established design control procedures for some device classifications. It is important to show ongoing compliance all the way from device conception through release to market.

To ensure ongoing compliance with quality system procedures, you should evaluate your pre-production QMS using internal audits at least once a year.  Conducting periodic internal audits also supports the evolution of the QMS when new processes are added to the system as the organization approaches launch of the product.

We can help you implement a pre-production QMS

Emergo has extensive expertise helping companies worldwide establish quality systems compliant with ISO 13485, FDA Quality System Regulation and other global QMS requirements. Our experienced consultants can establish procedures for regulatory compliance tailored to the specific markets you’re interested in entering.

 As part of your QMS implementation, we will set up procedures for the following:

  • Document and records control
  • Training on regulatory requirements and internal procedures
  • Design and development
  • Risk management
  • Software development (if applicable)
  • Supplier evaluation
  • Control of measurement equipment

We can also perform internal quality system audits if you do not have the staff or resources to do so.

Please contact us for more information about our pre-production QMS service.


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