Quality Engineering Capabilities
We provide end-to-end engineering and compliance solutions for all life cycle stages of your drug/biologic products, medical devices, and combination products.
Kymanox helps ensure combination product sponsors are ready to meet 21 CFR Part 4 regulations, help determine what are you missing in your current systems, and identify changes needed to existing systems.Start Getting More Done!
The Kymanox team is highly experienced in the strategy and system development and maintenance of Quality Management Systems (QMS) for Compliance to 21 CFR Parts 4, 210, 211, and 820.Start Getting More Done!
Kymanox has a proven track record of developing risk management and development strategies and maintaining risk management documentation across all modern medicine products.Start Getting More Done!
You can be confident in your compliance to design controls with Kymanox creating, maintaining, and remediating design history files (DHF) for all manner of combination products and medical devices.Start Getting More Done!
Meet our Quality Engineering Solution Experts
Markets That Benefit from Our Quality Engineering Solutions
The Kymanox Quality Engineering Difference
Kymanox delivers “Right First Time” results with the critical thinking and practical experience needed to meet regulators expectations.
We have executed numerous development and remediation programs, and have formed solutions to the industry’s challenges based on client specific feedback from regulatory bodies
Dynamic Project Management
A personalized approach to project management that combines your needs with our proven tools and expertise to create a custom solution for your project.
Kymanox prides itself on creating right-sized solutions for our clients based on their specific needs. We will help you avoid the hassle and cost of complex systems that may seem like a foolproof choice.
Frequently Asked Quality Engineering Questions (FAQs)
What is the greatest pitfall today during risk management activities?
Following ICH Q9 Quality Risk Management for drugs is no longer enough. More and more drug products now are categorized as combination products, and the definitions of requirements have changed significantly. The old ways of doing things don’t work anymore. The FDA has adopted a proactive, holistic approach to identifying and removing risks before they are realized, instead of focusing on the process for handling risks once they are identified.
Measuring Risk is about potential lost product, right?
Today you can no longer link your risk management tools to lost product or rejection of material, nor can you use economic considerations in the justification of enacting risk controls!! Risk is measured by severity of the harm to the user and patient, and the frequency that the harm will occur. In the past, severity could be based in a manufacturing framework, where the highest severity was “results in rejection of multiple batches or recall of lots on the market.” This speaks to an inherent business risk. In the combination product space now, you have to consider the harm to the user and/or the patient, which drives the risk reduction priorities.
I have a product in early development and I am considering different platform device for my drug product, do I need to implement design controls and risk management now?
Yes! It is critical to begin the documentation of your user needs with your specific intended use (i.e. emergency use device, prophylaxis, etc.). The first step to every good project is a plan, and design controls and risk management are no different. A Design and Development Plan, and a Risk Management Plan will ensure your device selection process is well defined with objective criteria, that your user needs are defined, and the correct requirements are laid out in the development process.
Do design controls and combination product development processes end at product launch?
No, design controls and lifecycle management are a living system that stay with the product throughout its entire lifecycle. Design History Files are living documents that are started in clinical development, and maintained until the product is retired from the market. Every change control requires an evaluation against the design of the product.
What are the high level elements of risk management?
Risk management includes the identification, evaluation, and control of hazards and harms to a user or patient that are associated with the use of a product. Risk is the combination of the severity of the harm and the potential occurrence of the harm. Risks pertains to the use of the product, the design of the product, and the processes by which the product are manufactured. All risks must be controlled and reduced as low as reasonably practicable, and all residual risks associated with the product must be weighed against the clinical benefits of the product, and must be signed off by someone with the clinical competency to assess both the risks and benefits of the product.
Read the Latest at Kymanox
Nathan Blazei Joins Kymanox as Head of Quality
Kymanox, a full-service life sciences solutions provider supporting commercialization of vital medicines and treatments, is proud to announce the addition of Nathan Blazei as Head of Quality. This new role will allow Kymanox to further enhance quality,...
On Demand Webinar: Lessons from Inspiring Women Science Leaders for International Women’s Day
https://kymanox.canto.com/direct/video/lfjpc5oos96hjeis95ger0ib6u/COge77h8J0ePzIoIvDXSggh3J_w/original?content-type=video%2Fmp4&name=KYM-IWD-Panel-08MAR2021.mp4 "As women, our ability to pivot and persevere when our lives become disrupted has become...
How the FDA Defines Combination Products
Is your product a combination product? Combination products are defined in 21 CFR 3.2(e) and more products than ever now fall into this category but many manufacturers are unaware of that fact nine types of combination products. The FDA identifies.Ta...