Quality Engineering

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.

01

Gap Assessments

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.

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02

QMS Support

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.

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03

Risk Management

Kymanox has a proven track record of developing risk management and development strategies and maintaining risk management documentation across all modern medicine products.

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04

Design Controls

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.

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Meet our Quality Engineering Experts

Nathan Cox

DIRECTOR, QUALITY ENGINEERING

Helpful Links

Here are some of our favorite resources on this topic

ISO 13485:2016 - Medical devices — Quality management systems — Requirements for regulatory purposes

QMS requirements where an organization needs to demonstrate its ability to provide medical devices and related services.

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FDA: CFR - Code of Federal Regulations Title 21

The often cited regulations governing regulations of combination products.

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ISO 14971:2019 - Medical devices — Application of risk management to medical devices

This standard describes risk management of medical devices, including software as a medical device and "in vitro" diagnostic devices.

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Markets That Benefit from Our Quality Engineering Solutions

Combination Products

Our experts understand the interaction between devices and drug products. Our experience includes injectables, nasal, respiratory, and more.

Biologics

We understand why “the product is the process” and how to implement solutions to your unique challenges.

Pharmaceuticals

Drug development is constantly evolving with new regulations and technology. We stay up to date to maintain your compliance.

Other

Our diverse experience across the life science industry, including medical device and vaccines, ensures your challenges are in expert hands.

The Kymanox Quality Engineering Difference

Kymanox delivers “Right First Time” results with the critical thinking and practical experience needed to meet regulators expectations.

Unmatched Expertise

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.

Right-Sized Solutions

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 a 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 life cycle 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.