Design Quality Services - Design Quality Services

Advancing Medical Device Innovation Through Training and Expertise

Designing and manufacturing safe medical devices is a complex endeavor.

Companies face design hurdles, manufacturing issues, and QMS-related concerns that threaten compliance and delay innovation. Without the right tools and training, business risks increase, and innovation slows.

Though obstacles can be significant, they don’t have to slow you down.

Our training and consulting services equip your team to overcome compliance hurdles, strengthen processes, and accelerate safe innovation.

Since 2017, DQS has supported medical device innovators, their patients, and clinicians with engineering tools and professional development solutions that strengthen both teams and devices.

If you’re looking to turn your challenges into confidence, we’d love to learn more.

Courses

Training that equips device engineers and quality professionals with the technical tools to design, validate, and deliver safe, compliant devices.

Training Library

Consulting

From start-ups to global firms, we help teams solve design, manufacturing, and compliance challenges with proven methods and customized solutions.

Consulting Services

At Design Quality Services (DQS), we’ve helped clients worldwide strengthen design practices and artifacts.

Our experience has been tested and validated with agencies and regulatory bodies worldwide. By applying robust engineering methods and leveraging a quality-minded culture, we help minimize rework, avoid failed submissions, and keep projects moving.

With decades of experience, let us make these activities easier:

User Need Generation
Design Input Authoring
Design Verification / Validation Strategies
Addressing Design File Gaps
QMS Non-Conformances
Audit Findings
EU MDR/IVDR Transitions

Risk identification and reduction are central to a safe medical device. Your Risk Management File (RMF) frames nearly every element of your business. We focus on:

Hazards / Hazardous Situation / Harm identification
Risk Control Measure (RCM) implementation and verification
Risk estimation / evaluation

We help companies accelerate their innovation pipeline using engineering tools, including

Failure Mode and Effects Analysis (FMEA)
Usability Engineering (UE)
Design of Experiments (DoE)
Risk-based Sample Size Selection
Manufacturing Control Charts
Others

At Design Quality Services (DQS) LLC, we have helped customers manage poor product designs and substandard design documentation for years.

We know what good looks like as we have defended our practices and client documentation with agencies and regulatory bodies worldwide.

There is never enough time to complete a device development project; however, poor design practices often lead to late design rework or a failed product submission. Utilizing robust engineering methods and a quality-minded culture will minimize these challenges.

Let us help you with the journey.

John has the ability to think broadly about business processes as a system, then bring them into consistent practice to shape behaviors and culture. He has expertise across the full spectrum of product creation including customer perception, business viability, original concept development, patent practices, program management, and regulatory compliance.

John has been an absolute delight to work with, handling the various challenges that have come our way with remarkable grace and efficiency. His expertise and positive attitude have truly made a significant difference in our collaborative efforts.

Ready to Equip Your Team With Proven Expertise?

Let’s get your medical device to market and your teams stronger.

Ostomy Devices to IoT Transition

Guided the transition of DC methods from single-use mechanical devices to intelligent IoT/cybersecurity-enabled devices.

Spinal Implant Manufacturer

Created and implemented custom Process Validation (PV) and Test Method Validation (TMV) methods.

Global OB/GYN & IVF Device Manufacturer

Rebuilt Design Control (DC), Risk Management (RM), and Post-Market Surveillance (PMS) methods across multiple sites.

Innovative Medical Device Start-Up

Designed custom sample size selection methods and tools for complex device verification.

Medical Device Contract Manufacturer

Upgraded d/p/uFMEA methods to support ambitious new development projects.

Global Disposable Device Manufacturer

Developed and implemented Usability Engineering methods in compliance with EU MDR.

Global IVD Reagents & Equipment Manufacturer

Established new NC/CAPA processes, templates, and PMS metrics.

Start-Up Device Companies

Provided independent technical/quality reviews to ensure robust development methods are in place.

Global Skin Contouring and Medical Laser Manufacturer

Overhaul of the product development process, including Design Control, SW Development, Usability Engineering, and Risk Management.