FDA Registered
Contact Us
Telephone: 616-233-3000
1440 Front Avenue NW, Grand Rapids MI 49504

Quality Assurance

ISO 13485 Compliance Is Our Point Of Difference

Fully-Digitized QA Program

ISO:13485 certificate

You know how companies put a stake in the ground and say, “This is what we stand for”?

Well, ISO 13485 quality assurance is our stake in the ground. This is what WE stand for – and have stood for since 2008.

Our ISO certification includes assembly, sterilization, and packaging of sterile and non-sterile medical devices.

We’ve invested emotionally and financially to continuously improve our quality assurance system as an ISO 13485 compliant medical device manufacturer. Our customers know the work product will meet every regulatory compliance standard.                                                                                                            Download PDF ISO:13485 Certificate

Quality System Procedures and Work Instructions

Ironically, we don’t have a Quality Department.

That’s because EVERYONE is in our “Quality Department.” With us, quality system documentation is maintained and controlled via a database that identifies the current revision and location of the controlled documents.

The Quality Policy Manual references Quality System Procedures and Work Instructions and outlines the structure of the documentation used in the quality system.

We document at four levels: Manuals, Procedures, Instructions, and Records. Read more >>

What Our Devotion To Quality Means To You

quality verification catheterIt is a given: You require a quality product. And every medical device custom manufacturer you meet will promise it to you.

When you shop, keep this in mind. You’ll need to track product quality and spend time on quality audits. That’s where we stand out.

When you run a quality audit with us as your ISO 13485 compliant medical device manufacturer, you’ll be shocked how easy, painless, and quick it will be. You’ll be in and out of our facility in a matter of hours, not days.

That’s because every employee’s job hinges on their adherence to our quality plan. Ask them!

They’ll tell you quality objectives are measured continuously and shared with the organization. Objectives are also periodically reviewed for completeness and appropriateness by our senior management, normally during the Management Review Meeting. We measure, manage, and improve:

  1. Long-term and trusting relationships with our employees, suppliers, and customers
  2. Skills and knowledge
  3. Equipment, methods, and processes utilized
  4. Operating results
  5. The Quality System in line with FDA QSRs and ISO 13485 requirements.

And we communicate this commitment as an ISO 13485 compliant medical device manufacturer over and over to them in the form of our Quality Policy Statement, Quality Policy Manual, Quality System Procedures, Management Reviews, Employee Meetings, and Continuous Training.

Yes we got them all done on time Clean room

Device Master Records

We establish a Device Master Record for each type or model of medical device. The Device Master Record contains or identifies documents defining product specifications.