Quality

Quality

Quality
Small to medium-sized manufacturing runs are conducted in our pilot production-controlled ISO class 7 cleanrooms.

Medical Murray provides our customers with the highest level of quality required for medical devices. We ensure the validity of all our processes, and provide consistent design, development, production and delivery of medical devices that are safe and effective.

Our experienced quality and manufacturing engineers are involved in all stages of your product's lifecycle and make recommendations on tools and design modifications to improve product manufacturability.

We utilize innovative, advanced technologies and processes which lead to sustainable, incremental gains through every stage of your products development.

ISO 13495:2016 & FDA Registered

All of our design and manufacturing services comply with FDA QSR 21 CFR – Part 820 and ISO 13485:2016. Our current ISO 13485:2016 Certificate of Registration is for the Design, Development and Analysis of Medical Devices along with Component Manufacturing and Assembly of Medical Devices.

Our Class 7 cleanrooms are also compliant with both ISO 14644 (Cleanrooms & associated controlled environments) and ISO 14698 (Cleanrooms & associated controlled environments - Biocontamination Control.)

To ensure that we maintain our quality standards, we are audited each year by our Notified Body, TÜV SÜD. We regularly perform Internal and External auditing, and frequently support customer audits. 

› Download our ISO 13485:2016 Certification

ISO 13485 Certificate
Quality Engineering

High Quality Product

Our engineering team continually employs process analysis and improvement tools to drive product enhancements. We test for reliability and performance to your specifications as well as compliance with identified regulatory requirements.

Product Inspection and Testing Capabilities include:

  • Lot release testing and inspections
  • Sterilization and biologics release
  • Compliant and failure analysis
  • Reliability planning and testing
  • Lab testing for analysis and compliance
Quality Engineering

Process Controls

To ensure that good quality assurance practices are used, early involvement of quality engineering is critical to ensure that quality is maintained and built into your product. We understand that safety and effectiveness are critical to the success of your medical device; therefore, we use risk-based decisions and validations to optimize your validation program and ultimately, reduce costs.


Quality Control Capabilities include:

  • Process validations (IQ, OQ, PQ) 
  • Test method validation
  • Software validation 
  • Gage R&R

Committment to Quality

Medical Murray is deeply committed to operation under the highest quality at every level of our company. We are dedicated to the full production of class II and class III medical devices in ISO Class 7 cleanrooms at all of our locations. We strive to design and manufacture products that meet or exceed customer requirements to help patients have a higher quality of life. 

Commitment to Quality

We’re ready for your next challenge!

We’re ready for your next challenge!

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NORTH BARRINGTON, IL
HEADQUARTERS

400 N. Rand Rd.
North Barrington, IL 60010
Ph: 847.620.7990
Fax: 847.620.7995
info@medicalmurray.com

CHARLOTTE, NC
8531 Steele Creek Place Dr
Unit D
Charlotte, NC 28273
Ph: 847.620.7990
Fax: 847.620.7995
info@medicalmurray.com

LAKE ZURICH, IL
540 Capital Drive
Suite 150
Lake Zurich, IL 60047
Ph: 847.847.3700
Fax: 847.847.3705
info@medicalmurray.com

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NORTH BARRINGTON, IL (HQ)
400 N. Rand Rd.
North Barrington, IL 60010
Ph: 847.620.7990
Fax: 847.620.7995
info@medicalmurray.com

CHARLOTTE, NC
8531 Steele Creek Place Dr. Unit D
Charlotte, NC 28273
Ph: 847.620.7990
Fax: 847.620.7995
info@medicalmurray.com

LAKE ZURICH, IL
540 Capital Drive, Ste. 150
Lake Zurich, IL 60047
Ph: 847.620.7990
Fax: 847.620.7995
info@medicalmurray.com

© 2020 Medical Murray