Stop paying twice for the same design work.
Rework eats 40 to 50% of device development budgets, and most of it starts with a requirement, a design input or a risk analysis that wasn't done right the first time. DQS courses build the capability to get those right, from design inputs to DFMEA, validation and risk management.
8 self-paced courses · built by practitioners · aligned to the QMSR, ISO 13485, ISO 14971 and IEC 62366-1
Top Medical Device Consulting 2026 MEDTECH Business Review
"Great material. Best I've ever seen in the industry." Mike Z., Senior Management Consultant
- $1Design
- $10Nonconformance
- $100CAPA
- $1,000Complaint
- $10,000Recall
Training isn't the expensive line item. Rework is.
Rework rarely shows up in a budget. It hides in requirements found incomplete after design freeze, verification that has to be repeated, and a design file corrected under audit pressure. The numbers are large, and they start upstream, where capability decides the outcome.
of product development cost goes to rework.
Charette, IEEE Spectrum; Wiegersof that rework traces back to requirements and specification errors.
Leffingwell, via Wiegersfirst-cycle 510(k) submissions draw an Additional Information request that stops the review clock.
FDA MDUFA V data, FY2018–2022of device-company sales is lost to the cost of poor quality. 1.5 to 3% is recoverable.
McKinsey & CompanyWhat it means for a 20-person engineering team
- Fully burdened team cost
- $3.0M / yr
- Spent on rework, at a conservative 35%
- $1.05M / yr
- Cut rework by just one fifth
- ~$210K / yr back
- Payback on the training
- ~4 months
Before counting a single day of faster approval. Add the value of reaching market sooner and the modeled return approaches 18 times the investment. Replace our inputs with your own numbers.
An engineer who knows what a robust design input looks like doesn't write the ambiguous requirement that forces a redesign. A team that knows what a reviewer expects doesn't submit thin validation that draws a deficiency letter. That is what we mean by capability, and it is what every DQS course is built to deliver.
Start from your role. Bundle a path and save $1,000.
Each path puts the courses in the order the work happens, so every course builds on the last.
Design Engineering Leader
Turn user needs into design inputs, a DFMEA and validation that hold up.
Quality / Design Assurance Leader
Review design files and risk files with the confidence to challenge them.
Manufacturing QA/QC Leader
Build processes that make conforming product every time, and prove it.
Risk Management Expert
Own safety and cybersecurity risk from design input to the risk management report.
Not sure where to start? Most teams begin with Design & Development, because every other course builds on design inputs. Or email John and describe your project.
Every phase of the device life cycle
Practitioner-built, self-paced, with live expert support before and after each course.
Design & usability
Design & Development
One framework from voice of the customer to design transfer, with your design and development file built as you go.
Design FMEA (DFMEA)
Failure modes, effects and causes that hold up, ratings you can defend, and priorities that steer the design.
Design Validation
Six validation types, from analytical to clinical, planned to show the device meets user needs the first time.
Usability Engineering & Human Factors (UEHF)
Use-related risk, critical tasks, and formative and summative evaluations that prevent use errors.
Risk management
One method, across every engineer and every product line.
When the whole team learns the same approach, design files look the same, reviews go faster and new hires get productive without reinventing the format.
- Volume pricing and group enrollmentEach engineer gets their own login, materials and expert support.
- Completion certificates for your training recordsCourse, date and hours, ready for ISO 13485 and QMSR competency evidence.
- Your examples, for larger teamsCourse examples and language can be adapted to your products.
- Multiple languages, coming soonThe library will be offered in more languages, so teams in different countries can train on the same method.
Dr. John Salvato
John has spent more than 30 years in medical device and automotive quality and regulatory work. Since founding DQS in 2017 he has rebuilt design control, risk management and FMEA methods for device makers around the world, and defended that work with agencies and regulatory bodies. The courses are his methods, not a reading of the regulations.
"What we offer is capability-focused training. We understand the regulation, but we are also going to teach you how to implement it smartly."
Medical devices give sight, restore mobility and buy families time. Behind every one is a team trying to ease suffering. We train those teams to get it right the first time.
Start with the free material
The Capability Edge
Real-world methods from the audits, submissions and inspections that actually happened. Free, monthly.
GuidesPractical guides
Design controls, design reviews, P-diagrams, safety risk analysis and FDA cybersecurity, free to download.
Free webinar · 10–12 Nov 2026The Capability Edge Live
Three 45-minute sessions on the gaps reviewers see, what they cost, and how to build capability.
Questions people ask
Who developed these courses?
How do I get support if I get stuck or have a project question?
Can I fit this into my schedule?
Are the courses aligned with current FDA and ISO requirements?
Can my whole team take the courses?
Will my team receive a certificate of completion?
Sources: Charette, "Why software fails," IEEE Spectrum (2005) and Leffingwell (1997), as cited in Wiegers, "When bad requirements happen to nice people," Jama Software; FDA MDUFA V data as reported by Hyman, Phelps & McNamara, FDA Law Blog (2023); Fuhr et al., "Capturing the value of good quality in medical devices," McKinsey & Company (2017); 1-10-100 rule, WorkClout (2021). Team model from the DQS white paper "The Business Case for Technical Training in Medical Device Development" (2026).
Get it right the first time.
Build the capability that keeps rework out of your budget and deficiency letters out of your submissions.