Own safety and cybersecurity risk from design input to the risk management report.
Three courses that build a complete risk practice: design and development as the foundation, safety risk management under ISO 14971, and cybersecurity risk management under FDA premarket guidance and AAMI SW96.
Training a team or paying by purchase order? Email us
3 courses · $3,000 instead of $4,000 · save $1,000
- 01Design & Development$1,000
- 02Safety Risk Management (SRM)$1,500
- 03Cybersecurity Risk Management (CRM)$1,500
3 courses, in the order the work happens
Own safety and cybersecurity risk from design input to the risk management report.
-
Step 1
Design & Development
One framework from voice of the customer to design transfer, with your design and development file built as you go.
$1,000 aloneCourse details → -
Step 2
Safety Risk Management (SRM)
Risk acceptability, benefit-risk evaluation and a risk management file that stands up in review.
$1,500 aloneCourse details → -
Step 3
Cybersecurity Risk Management (CRM)
SPDF and STRIDE threat modeling so security strengthens your submission instead of stalling it.
$1,500 aloneCourse details →
Design & Development first
Risk controls only work when they become design inputs that are verified. This course shows how risk management plugs into the design and development file.
Then safety, then security
Safety Risk Management builds the ISO 14971 process. Cybersecurity Risk Management extends it to security risks, with threat modeling, SBOM and CVSS, and shows where the two meet.
After the path, you will be able to
Make risk controls part of the design
Turn risk controls into design inputs and trace them through verification and validation.
Run a risk process that stands up in review
Estimate risk, set acceptability, evaluate benefit-risk and write a risk management report a reviewer can follow.
Threat model the device
Apply a Secure Product Development Framework, threat modeling and an SBOM to find and control security risks.
Bring safety and security together
Show where security risks become safety risks, and manage vulnerabilities after release.
Built by practitioners, with support when you need it
- Self-pacedWork through each course on your own schedule.
- Quizzes and a final examIn every course, to confirm you have it before moving on.
- Live expert supportAsk DQS about the material or your own device.
- Completion certificatesCourse, date and hours for your training records.
"Great material. Best I've ever seen in the industry."Mike Z.Senior Management Consultant
One method, across every engineer on the team.
When the whole team takes the same path, design files look the same, reviews go faster and new hires get productive without reinventing the format.
- 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 built design control, risk management, FMEA and validation methods for device makers around the world, and defended that work with agencies and regulatory bodies.
"What we offer is capability-focused training. We understand the regulation, but we are also going to teach you how to implement it smartly."
Questions people ask
Do I have to take the courses in order?
Can I buy the courses one at a time instead?
I already own one of these courses. Can I still get the path?
How do I get support if I get stuck?
Will I get a certificate?
Can my whole team take the path?
Risk Management Expert: the whole path, one price.
Own safety and cybersecurity risk from design input to the risk management report.
$3,000 for 3 courses · save $1,000 · self-paced
Training a team or paying by purchase order? Email us