262-781-7122

 

MRPC’s overall goal is to create and sustain a Quality Culture. We use numerous quality and operational metrics to drive/communicate a culture of quality throughout our organization.

MRPC is continuously reviewing our quality system to make improvements and expand our system.
We do this through:

  1. Collaboration with our customers
  2. External audits
  3. Sharing program knowledge

 

Per our Mission Statement and Quality Policy, MRPC’s staff has a complete understanding that we manufacture products that affect the lives of patients. We produce each component and device knowing that patient safety and manufacturer integrity is greatly important.

Regulatory and Compliance

 

MRPC is an ISO 13485 certified company and has held this certification since 2009.

 

MRPC was one of the first manufacturing companies in the state of Wisconsin to gain ISO 13485 certification. With our longevity in utilizing our ISO System, MRPC has a strong procedural foundation that has allowed our quality approach to be second to none.

Beyond our ISO certification, MRPC offers FDA Registration (as a contract manufacturer), NSA compliance capabilities and is NSF certified.

 

Product Validation Expertise

MRPC’s Quality Staff has complete understanding and experience in performing product validations. Our experienced staff has put together PPAP’s, IQ’s, OQ’s and PQ’s, and FAT for individual components and assembled finished medical devices.

Standard items in our PPAP/Validations are:

We also utilize MiniTab for all capability analysis provided in our validations.

  1. Process Flow Diagram (PFD)
  2. Process Control Plan (PCP)
  3. Potential Failure Modes and Effects Analysis (PFMEA)
  4. Gage R&R/MSA
  5. Traceability

 

Quality Expertise

The knowledgeable quality staff at MRPC has over 100 years of combined quality experience that spans across different industries, including Medical, Automotive and Aerospace. Our knowledge covers an array of standards that are used in multiple industries.

Standard experiences are:

  1. ISO 9000
  2. ISO 13485
  3. ISO 14001
  4. OHSAS 18001
  5. TS 16949
  6. QS 9000
  7. AS9100
  8. 21 CFR 820

 

Sterilization Management

MRPC sterilization consultation and management team assists in identifying an ideal sterilization method for products, and manages the process with contract sterilization providers. We are there to support the initial sterilization validation, as well as the ongoing processing activities for our clients.

Certified Clean Rooms

 

All MRPC facilities are environmentally controlled. MRPC offers ISO 7 (Class 10,000) and ISO 8 (Class 100,000) cleanrooms for molding, finished device assembly, and sterile packaging. All our clean rooms are tested and certified annually by a third-party source. The clean rooms have an automated monitoring system that sends an alarm when the parameters (temperature, pressure, and humidity) move out of range. Air particulate checks are completed per the recommended intervals to ensure cleanliness.