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MRPC’s overall goal is to create and sustain a Quality Culture.

Per our Mission Statement and Quality Policy, MRPC’s staff completely understands that the manufacturing process creates products that affect patients’ lives. We produce each component and device knowing that patient safety and manufacturer integrity are critical.

In addition to the above, MRPC maintains a single Quality Management System (QMS) for all locations, where the key performance indicators align and support the MRPC Quality Objectives.

MRPC continuously reviews the QMS for effectiveness and to identify improvement opportunities.  We do this with a cross-functional approach and through:

  1. Collaboration with our customers
  2. Internal audits, and external 2nd and 3rd party audits
  3. Sharing best practices with partners and professional associations

 

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 QMS, MRPC has a strong procedural foundation that has allowed our quality approach to be second to none.

MRPC received MedAccred® Injection Molding accreditation for demonstrating an ongoing commitment to quality by satisfying customer requirements and industry specifications.

MedAccred Accredited

MedAccred® is an industry managed supply chain oversight program that reduces risk to patient safety, assures quality products and compliance with requirements as they apply to critical processes used in the production of medical devices. The program is administered by the not-for-profit Performance Review Institute®.

Beyond our ISO and MedAccred certification, MRPC offers FDA Registration (as a contract manufacturer), and maintains a system for Device Master Records (DMR) and Device History Records (DHR).

 

Product Validation Expertise

MRPC’s Quality and Engineering teams employ a cross-functional approach with a complete understanding for the development and completion of validations utilizing specific IQ OQ PQ protocols for individual components and assembled finished medical devices.

The IQ OQ PQ validations become confirmation of MRPC’s Advanced Product Quality Planning (APQP) which is a phased approach utilizing some building blocks for successful product introductions:

  1. Process Flow Diagram (PFD)
  2. Process Control Plan (PCP)
  3. Process Failure Mode and Effects Analysis (PFMEA)
  4. Test Method Validation (TMV)
  5. Process Capability Analysis (PCA)

MRPC utilizes Minitab® for all capability analysis provided in our validations. In addition to testing data and detailed lot tree traceability records, MRPC also provides detailed Certificate of Conformance packages.

Quality Management Systems

The staff at MRPC has hundreds of years of combined experience that spans across multiple industries. This experience has enabled MRPC to integrate multiple standards and best practices into a single business management system.

  1. ISO 13485: Medical Devices
  2. MedAccred Accreditation
  3. 21 CFR Part 820: Quality System Regulations (including cGMP)

 

Other References:

  1. ISO 14001: Environmental Management Systems
  2. ISO 45001: Occupation Health and Safety Management System
  3. ISO / IEC 27001: Information Security Management System
  4. ISO 9001: Quality Management Requirements

 

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. Where appropriate MRPC has the defined microbial and surface testing to support sterilization processes.

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 and finished device assembly. All our clean rooms are tested and certified annually by a third-party source. Air particulate checks are completed per the recommended intervals to ensure cleanliness.