Quality Assurance Best Practices in Contract Manufacturing

KMCSystems_Quality_Assurance_Tip_SheetSeveral factors play into a successful contract manufacturing program. Some of these factors result in reduced expenditures, increased time saving capabilities, and error free development practices. For 35 years, KMC Systems has been continuously refining our manufacturing processes to successfully and seamlessly bring compliant medical devices to market. KMC Systems produces groundbreaking medical instrumentation by leveraging our years of experience and employing three key priorities for quality assurance during the design, development and manufacturing phases.

These key best practices are: 

  1. Establish customer expectations from the start
  2. Integrate a robust Quality Management System (QMS) 
  3. Develop a cost-effective quality plan 

With these 3 best practices in place, you can ensure compliance with FDA regulations, practice quality assurance versus quality control, and integrate quality management systems to allow for adherence of regulatory requirements.

In a recent blog post, Gail Weigand, director of quality assurance and regulatory compliance at KMC, sums up the importance of the quality process perfectly:  “Our proprietary software helps us meet our customer’s requirements for quality, delivery and a cost-effective solution. It has been proven time and time again to be built and managed in compliance with the ISO 13485 standard and the FDA regulations. The amount of data captured in our Notes applications is incredible, and it is data that drives KMC to make decisions, initiate actions and establish quality objectives.”

With robust quality assurance as an integral part of KMC Systems' proven process, we focus on open collaboration between all departments during the design, development or manufacturing phase of a medical instrumentation project. Customers play a key role in this collaboration and are informed of product performance results and testing updates every step of the way. This accelerates the development process, in turn managing operation costs and development risks.

At KMC, we are continually staying up to date on industry trends, techniques and are always refreshing our knowledgebase. Participating in quality communities, training sessions, conferences, webinar trainings and seminars, KMC is able to stay current with the latest quality regulations and standards.

Individuals within the company also belong to the Regulatory Affairs Professionals Society, the ASQ: The Global Voice for QualityAssociation for the Advancement of Medical Instrumentation(AAMI) and attend presentations provided by MassMEDIC to receive first-hand updates from FDA personnel.

To learn more about KMC Systems' quality assurance best practices, download the tip sheet here.

KMC Quality Assurance Tip Sheet

Another way to stay up to date in the medical manufacturing industry is to attend tradeshows.  Currently AACC 2015 is underway and numerous industry leaders are in attendance and speaking. With many valuable sessions lined up, the AACC2015 quality assurance session is sure to hit the mark: 43124 Challenges of Quality Control in Modern Analytical Systems

The KMC team will be at AACC 2015. Stop by booth #2851 to talk about quality assurance and your upcoming medical instrumentation projects. 

KMC Systems will be tweeting about the expo! Join the discussion on Twitter using #AACC2015 in your tweets!  Be sure to follow @KMCSystems and @_AACC.

Topics: medical device development, medical device quality assurance, medical manufacturing quality management, quality assurance