Quality

Quality is Critical at Minnesota MedTec

At Minnesota MedTec, we understand that the products and components we produce are helping the lives of family members, grandparents, and children. We can not make any mistakes.

We meet with our customers and determine all risks, measuring methods, standards, and delivery dates needed to ensure the safety needs and delivery schedules for the products we manufacture.

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ISO Certification
FDA
Registered & Certified
Controlled Manufacturing Areas
Testing
Biologics
Validations
Verifications and Qualifications
Quality Manual
Route Based Ordering System
Control Plans
Standard Test Methods

ISO Certified 13485 :2016

Minnesota MedTec is a contract Manufacturer and must meet a variety of standard to qualify as a certified medical device manufacturer.

As indicated in the ISO standards , ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.

Minnesota MedTec’s regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.

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FDA Registered

Minesota MedTec is registered as a finished device manufacturer.  Our Registration number is 2134626.

Registered & Certified

Minnesta MedTec has been inspected by 100’s of companies and certified as a qualified medical device manufacturer from various organisations in many countries such as Korea, Japan, Brazil, China, UK and more.

In the United States, we are registered as a final device manufacturer and are open to inspections and are routinely inspected  from our customers and organisations such as the Food and Drug Administration.

Controlled Manufacturing Areas

Minnesota MedTec designs its processing based on the needs of its customers and also based on the process needs.  We produce products with two basic environmental concerns.

  1.  Product quality: Many of our products require clean room manufacturing based on our customers requirements. We have various areas to manufacture products from warehouse to our biologically controlled clean rooms.
  2. Cost: Some of our medical device customers don’t require us to produce the products in a controlled environment at all to help reduce the costs of the products.  These products may require a final clean or have the final steps completed in one of the clean rooms.

Testing: Bioburden and Pyrogen

Periodically our manufacturing areas and personnel are tested for biological elements using petri dishes and standard test protocols.

Additional testing can be added to processes as desired by specific product lines.

Pyrogens are a foreign substance that causes a fever or elevated temperature in a human body. Typically,pyrogenic substances include endotoxin and other bacterial byproducts. Medical devices must be confirmed to be “pyrogen free”  to specific levels according to regulatory requirements of medical device directives.

Many products and components produced at Minnesota MedTec are routinely tested based on our customers needs for Pyrogens and our processes are made to accommodate those customers that would like their products tested.  We do not test all the processes routinely for pyrogenic substances to reduce the cost for products that don’t need the testing.

Biologics

Minnesota MedTec tries to minimize the amount of costs during its manufacturing processes however, many costs can’t be avoided when medical devices are concerned.

Medical device or materials used in a medical devices that comes in direct contact with a human patient must be able to perform its intended function without inducing significant rejection or adverse reaction in a patient. The degradation or leaching of chemicals and other device materials may lead to effects on a patient, and potential adverse reactions can range from the rejection of the device by the body to longer term reproductive or developmental effects.

For these reasons, medical devices and materials are typically subject to a range of biological, physical and chemical tests to ensure that the benefits offered by the device exceed any potential risks to a patient as a result of the device itself or the materials used in the device.

Facility design and control considerations for commercial manufacturing processes include environmental controls (e.g., temperature, humidity, and pressure), air quality (e.g., particulate and microbiological), facility finishes, gowning and flow procedures, equipment containment, system integrity, and cleaning procedures.

At Minnesota MedTec, we evaluate the risks when we receive orders from our customers and produce the products based on their requirements.

Validations

During our first meeting on a new project or customers request, Minnesota MedTec will ask if you need any type of validations or verification’s for the product.

  • Validation- Establishes documented evidence which provides assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes. Consists of an equipment qualification and performance qualification. Equipment qualification focuses on the equipment rather than the processes or product itself. Performance qualification is that phase of validation which is directed at process and product attributes. These activities are generally performed in sequential order.
  • Equipment Qualification- A combination of an installation Qualification and an Operational Qualification:
    • Installation Qualification- Documentation that the installation of a piece of equipment conforms to specifications.
    • Operational Qualification- Documentation that the operating performance of a piece of equipment conforms to operating specification and establishes confidence the process equipment and ancillary systems are capable of consistently operating with established limits and tolerances. Performed in the absence of production materials or components.
  • Performance Qualification- A phase of validation which establishes that the process demonstrates effectiveness and reproducibility. In challenging a process to assess its adequacy, it is important that the challenge conditions simulate those that will be encountered during actual production, including “worse case” conditions. The challenges should be repeated sufficient times to assure that the results are meaningful and consistent.
  • Validation Protocol- A written plan stating how validation will be conducted, including test parameters, product characteristics, production equipment, and decision points  on what constitutes acceptable test results.
  • Calibration- Demonstrating that a measuring device produces results within specified limits of those produced by a reference device over an appropriate range of measurements. The validation must demonstrate that all significant equipment are calibrated and operate properly during validation events.
  • Verification- Verification is performed during product/process development to ensure that the requirements or specifications are met. Verification does not prove consistency or capability. Verification is also used during equipment and software installations to verify that the proper connection or operation is functional.
  • Worst Case- A set of conditions encompassing upper and lower processing limits and circumstances, including those within standard operating procedures, which pose the greatest chance of process or product failure when compared to ideal conditions. Such conditions do not necessarily induce product or process failure.
  • Most equipment will have IQ’s completed but new equipment will need to have the installation qualified to ensure that the equipment was installed properly.  After the installation, the equipment is performing up to its operational requirements.

Verifications & Qualifications

Our customers have different views and opinions concerning “Verification” & “Qualifications”.   At Minnesota MedTec, we complete our product verification & qualification base their needs and the regulatory requirements they have.

All tooling will be validated to verify that the new tooling is valid to be used and also if the new tooling requirements have attributes  that are not measurable, we require parts to be produced from the tool to make sure the parts are valid to the specifications.

Quality Manual

All aspects of our company quality is desperately important to us.  Our quality manual is our guiding document for us and also for our customers to use to ensure that we produce the best products possible.

In this manual, we describe all of the quality systems, facility and operations used for planning, implementing, coordination and assessing the quality management system.

Route Based Ordering System

One of the most difficult aspects to economic efficiencies is the cost and burden of regulatory requirements.

It has taken Minnesota MedTec 25 years to perfect the art of decentralized cost and performance structures.  The problem with having systems in place is that the systems become a burden to companies and all processes become centralized around the “system”.

Because most companies need products produced based on their individual needs, we have created a system that is designed to accommodate inventors and companies that require six sigma quality control systems alike with our route based approach.

As an example, our Route based approach doesn’t place all of the burden on products from the start just to prove out a concept. It allows concept projects to have its own unique system; documentation is just between one of our engineers and the customer where an ECO system just adds costs and is a takes slower system.

Control Plans

At Minnesota MedTec we strive and use various tools to evaluate product lines for quality and costs associated with the product lines.

Control plans are one of the tools used to help reduce waste in a process. MMTI tries to reduce waste everywhere possible and it also improves quality by identifying the sources of variations in processes and establishes controls to monitor them. By focusing on what is critical to quality during the process, you can reduce scrap, eliminate costly reworks and prevent defective product from reaching the customer. When scrap and reworks are reduced, throughput of the process is inherently improved. Manufacturing efficiency is improved and our company’s bottom line is impacted in a positive manner.

Standard Test Methods

Standard test methods are used to compare properties and /or results of a test.

During the past 25 years in business with hundreds of customers, Minnesota MedTec has been involved with very creative ways of doing tests to compare properties and attributes of catheters and assemblies.

We have developed very unique test methods that are focused on properties that go beyond standard ISO and ASTM test standards.  A couple of examples areas to determine  the pushability or torqueability of a catheter as it is being pushed into a human body.

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