Quality and Regulatory

Quality and Regulatory

Quality and Regulatory

M&K Engineering ensures customer satisfaction and product safety through a robust and continually enhanced Quality Management System that is 21 CFR 820 FDA Quality System (QS) Regulation compliant as well as ISO 13485, AS9100, and ISO 9001 Certified. Our comprehensive QMS encompasses the essential elements necessary for the production, and distribution of innovative medical implants and surgical tools that meet today's challenging healthcare expectations.

ITAR Compliance

The International Traffic in Arms Regulations, or ITAR, is a set of government rules that control the export and import of defense-related articles, services and technology on the U.S. Munitions List (USML). It is a collection of critical compliance requirements that help to ensure defense technology and related technical information does not fall into the hands of anyone who is not expressly intended to have it.

FDA Registration

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration.

Although M&K Engineering is not considered to be a finished medical device manufacturer as a contract manufacturer, we feel it is of significant importance that we hold our company accountable to the same degree of regulatory compliance as our customers. M&K Engineering is an FDA Registered Organization, registration number 3011765094.

ISO Certifications

ISO International Standards ensure that products and services are safe, reliable and of good quality. For business, they are strategic tools that reduce costs by minimizing waste and errors while increasing productivity. ISO Certifications help companies to access new markets, level the playing field for developing countries and facilitate free and fair global trade.

M&K is dedicated to adding real and measurable value at any and every stage of the medical device development process. Our success depends heavily on our understanding of and adherence to the quality standards put forth by ISO 13485, AS9100, and ISO 9001. We take great pride in the results of our ISO surveillance audits to continually improve our company’s cultural commitment to quality and excellence.

Click the Icons to obtain copies of our ISO Certifications

     

Risk Management – ISO 14971 Compliance

ISO 14971 is an ISO standard for the application of risk management to medical devices. As part of M&K Engineering’s commitment to providing the utmost in quality parts, we maintain compliance to ISO 14971 in order to identify and mitigate any possible risk to our parts and assemblies. Both process risk and end use risk-based thinking are used to deliver the best quality product to our customers.

Process Validation (IQ/OQ/PQ)

Installation Qualification (IQ) Evaluates the means of accommodating new equipment and testing it’s materials.

Operational Qualification (OQ) Is essential in challenging your equipment parameters.

Performance Qualification (PQ) Puts the equipment to the final test.

Before you even get to IQ, OQ, PQ, if you’re acquiring a new piece of equipment, you’ll need design specifications that define exactly what’s in that piece of equipment. Everything from the type of power source it will utilize to the exact materials used in its construction. 

At M&K Engineering we qualify all new equipment in compliance of IQ/OQ/PQ regulations per 21 CFR 820.75. We are continually monitoring processes and revalidating as necessary.

Quality is the foundation of M&K Engineering's success. M&K is one of only a few manufacturing companies in the country to hold three ISO certifications and continues to uphold a quality rating over 99% annually. M&K Engineering is considered a dock to stock supplier in both the aerospace and medical markets. Techniques utilized by M&K and offered to our customers are:

  • FMEA Risk Assessment
  • IQ/OQ/PQ
  • PPAP
  • Gage R&R
  • SPC

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