Medical device startups have a pile of things to address yet often don’t have the pile of money to take care of everything that is needed. Because of this, a medical device quality system often gets pushed to the back burner in favor of activities that are perceived to add more value and meaning to the startup. Ignoring a quality system entirely until after development is complete and the product is launched is not a good idea. A medical device startup should treat the development of a quality management system in a similar fashion as the development of a medical device. Learn how to build your medical device quality system as you go.

1. 4 Quality System Musts for
Medtech Startups to get
Safer Products to Market Faster

2. ABOUT THE PRESENTER
• 20+ years in medical device industry
• Product development engineer, quality
manager, regulatory specialist
• 40+ products to market
• Expert at QMS implementations
• Dozens of ISO audits & FDA inspections
Greenlight Guru produces beautifully simple
quality, design control and risk management
software exclusively for medical device
manufacturers.
Jon Speer
Founder and VP of QA/RA of Greenlight Guru
Jon.Speer@Greenlight.Guru
+1 (317) 960-4280

3. TRUSTED BY LEADING MEDICAL DEVICE
COMPANIES IN MORE THAN 50 COUNTRIES
“Greenlight Guru has enabled us to implement our quality system
across the company and accelerate product development”
Greg Sommer, CEO & Co-founder
Sandstone Diagnostics, Inc.
“I have a high degree of confidence that as changes to the
regulations occur, I won’t have to worry about being out of
compliance because I am using Greenlight Guru”
Evan Luxon, CEO & Co-Founder
Centese
“I was actually a little nervous going into the audit, because it
seemed too effortless. I've worked in QA at a Fortune 500
company with a custom solution. Your flow is better.”
Linda Cox, Senior Vice President QA
Solius

4. MEDICAL DEVICE QUALITY IS ALL WE DO, AND
WE’RE ALWAYS AHEAD OF THE GAME

5. Help you understand the most important
processes a medical device QMS must have early-
on to ensure compliance
My Goals for Today
1

6. Show you how to get your products to market
faster with less risk allowing you time to do your
actual job
My Goals for Today
2

7. Help you make the shift from focusing on
compliance-only to adopting a TRUE QUALITY
mindset
My Goals for Today
3

8. Let me share the three cornerstones
of my QMS philosophy …

9. A QMS should be commensurate with the
product / company stages and milestones.
Bootstrap your QMS
1

10. A QMS should meet the intent of regulations and
sufficiently describe a company’s processes. No
No More. No Less.
Keep your QMS simple
2

11. The QMS you have in place should be tailored to
the size and type of company you are.
Right-size your QMS
3

12. A Medical Device QMS must…
Leverage the best
1. People
2. Processes
3. Technology

13. Result of leveraging best People, Processes, and
Technology:
• Opportunity for better integration across entire QMS
• Improved efficiency
• Better alignment with global regulatory bodies
• Medical devices that are safer and more effective

14. Realize this...
A best practice QMS implementation
achieves two, primary missions:
1. Aligns with applicable regulations
2. Describes the processes and
practices within your company

16. QMS MUSTS TO GET
SAFE PRODUCTS TO MARKET FASTER

17. GO-TO-MARKET QMS PROCESSES
• Design Controls
• Risk Management
• Document Control & Records Management
• Supplier Management

18. DESIGN CONTROL
#1

19. 820.30(h) ISO 13485:2016 7.3.8 Design Transfer
SOURCE OF
MISCONCEPTIONS
a. Design & Development
Planning
21 CFR PART 820.30 DESIGN CONTROL
Planning
Design
Input
Design
Output
Design
Review
Design
Verification
Design
Validation
Design
Transfer
WHICH GETS VISUALIZED AS:
Design & Development Planning
Design Input
Design Output
Design Verification
Design Validation
Design Transfer
Design Review
BUT THE PROCESS REALLY LOOKS MORE LIKE THIS:
e. Design Verification
f. Design Validation
g. Design Transfer
h. Design Changes
b. Design Input
c. Design Output
d. Design Review

20. DESIGN CONTROL PROCESS
1. Capture User Needs (including intended use).
2. Establish a Design & Development Plan.
3. Define Design Inputs (all those requirements).
4. Have a Design Review.
5. Design your product. Document Design Outputs (drawings,
specifications, etc.).

21. DESIGN CONTROL PROCESS (continued)
5. Conduct a Design Review
6. Prove you designed the product correctly with Design Verification.
7. Have a Design Review.
8. Prove you have the right product with Design Validation.
9. Transfer from development to production.

22. MAINTAIN ALL DOCUMENTATION AND
RECORDS IN YOUR DESIGN HISTORY FILE

23. RISK MANAGEMENT
#2

24. Risk-based QMS
• ISO 14971 risk management approach serving
as a foundation for QMS
• ALL QMS processes utilize risk-based approach
• ALL QMS processes “feeding” into product
risk management
• Risk-based QMS is about managing your business

25. RISK MANAGEMENT PROCESS OVERVIEW

26. STEP 1: Establish Risk Management Framework
• Define your risk management process
• Establish management roles and responsibilities
• Document your risk management plan
• Establish a living risk management file

27. STEP 2: Specify Intended Use
• Understand and define scope of your device
• Document its intended use

28. STEP 3: Identify Hazards
• Identify potential sources of harm (hazards) associated with your
device
• Document all hazards

29. STEP 4:
• Estimate risk of all hazardous situations that may occur
• Estimate risk of all foreseeable sequences of events that may occur
Define Hazardous Situations &
Foreseeable Sequences of Events

30. STEP 5: Estimate Risk
• How to calculate risk:
SEVERITY OF POTENTIAL HARM
PROBABILITY OF HARM OCCURING
X

31. STEP 6: Evaluate Risks Identified

32. STEP 7: Risk Control
• Use Risk Controls to
reduce risks to
acceptable levels

33. STEP 8: Evaluate Overall Risk Acceptability
• Evaluate risk of your device in its entirety
• Is the risk level acceptable?
• Do the benefits outweigh potential risks?

34. STEP 9: Risk Management Review
• Review risk management
• Prepare risk management report PRIOR to manufacturing

35. STEP 10: Production & Post-production Information
• Risk management is
a total product
lifecycle process Internal audits
CAPAs
Complaints
Customer Feedback

36. DOCUMENT CONTROL &
RECORDS MANAGEMENT
#3

37. “IF IT WASN’T DOCUMENTED,
IT DIDN’T HAPPEN.”

38. Document Control & Records Management
• Define how your documents get approved.
• Define how you maintain revisions.
• Generate and maintain records resulting from product
development.

39. SUPPLIER MANAGEMENT
#4

40. Examples of Suppliers
• Designers
• Material third parties
• Test firms

41. HOW DO YOU KNOW
IF YOUR SUPPLIER IS QUALIFIED?

42. SUPPLIER QUALIFICATION PROCESS
• Define how you qualify suppliers
• Define how you evaluate suppliers
• Define how you monitor suppliers
• Define how you manage suppliers
• Create an approved supplier list (ASL)

43. THEN…
STOP

44. YOUR OPTIONS FOR A QMS…

45. Paper-based quality systems are not the cheapest
and easiest type of QMS to implement ...
... even if you’re an early stage company, have little
to no funding, and with a product still in R&D.

46. • Storing documents on physical paper
• Examples include Google Docs, Excel, SharePoint, and
Dropbox.
• Typically, a paper-based system will be a combination
of all these methods.
Paper-Based QMS

47. • Upgrade from paper-based solutions
• Designed to manage quality processes across multiple
industries
• Does not integrate regulatory standards
• Does not include industry-specific templates and best
practices
General Purpose Tools & Legacy QMS Software

49. CRITERION PAPER & AD-HOC SYSTEMS GREENLIGHT GURU BENEFITS W/ GREENLIGHT GURU
Alignment to Regulatory
Requirements
Must be manually built and kept up with the
changing regulations
Built-in guardrails that align with FDA, ISO, EU MDR,
and MDSAP best practices
As changes to the regulations occur, you won’t
have to worry about being out of compliance and
you’ll be nimbler in entering new markets
Document Control
Physical cabinets or basic digital document
storage with wet signatures and file scanning
Cloud-based advanced document controls with
robust permissions, change control, and e-
Signatures
Eliminate wet signatures; Reduce time spent on
document control; maintain visibility and control
over sharing
Design Controls
Managed via ad-hoc & disconnected document
& spreadsheets; DHF’s take 4-6 weeks to
compile
Purpose built capabilities for managing design
controls; DHF’s generated on demand
Less engineering time spent on non-value-added
paperwork & activities; Higher quality device
submissions due to having reliable, structured
design history data
Integration of Risk
Managed via ad-hoc & disconnected document
& spreadsheets
Fully integrated with Design Controls in ISO 14971
compliant manner
Maintain closed-loop traceability and alignment
with industry risk requirements
Design Reviews
Offline – time consuming to plan, manage, and
document
Online – simple to plan, assign, & manage; design
review artifacts automatically generated
Accelerated product development timelines,
reduced likelihood of design review details and
documentation negatively impacting an audit
Closed-Loop Traceability
Requires significant effort and resource
allocation to document
Achieved through integrated Design Controls, Risk,
fully traceable workflows and LinkAnything
capabilities
Lowers burden of demonstrating CLT, increasing
audit confidence and readiness
Ease of Use Employees manage the system via brute force
Simple to implement and easy for team members to
learn and use
Employees embrace the quality system rather
than fighting the system
System Validation
Ad-hoc processes or system must be validated
individually by internal resources or costly
consultants
Part 11 compliant software validation package
(IQ/OQ/PQ) included
Lowers Total Cost of Ownership, expedites time
to value, allows companies limited resources to
not get bogged down in mindless software
validation activities
Advisory Services External – QA/RA Consultants
Guru Advisory Support Packages & Partner
Network
Gain insights that span QA/RA and technology
systems from experienced medical device
professionals that increase ability to navigate your
QMS alongside industry best practices
System Scalability
Challenging to scale manual / ad-hoc
processes; Ongoing costs
Scales with ease
Right-sizing QMS to meet your needs throughout
the lifecycle of your business; investment in
quality

50. CRITERION GENERAL PURPOSE EQMS SOLUTIONS GREENLIGHT GURU BENEFITS W/ GREENLIGHT GURU
Alignment to Regulatory
Requirements
Minimal; can be achieved through advanced
configuration, plugin tools, or workarounds that
require upkeep as regulatory changes occur
Built-in guardrails that align with FDA, ISO, EU
MDR, and MDSAP best practices
Avoid costly and time-consuming software re-
validation efforts; QMS will stay ahead of changing
global markets
Document Control
Common to have role-based permissions, many
systems don’t support uploading and controlling
CAD drawings
Advanced document controls with robust
permissions, change control, and e-Signatures;
support for a myriad of file types
Establishes single source of truth for all design
control, risk, and quality documentation
Design Controls
Offline documents and spreadsheets acting as
system of record managed through Doc Control
Purpose built capabilities for managing design
controls; DHF’s generated on demand
Less engineering time spent on non-value-added
activities; Higher quality device submissions with
reliable, structured design history data; Audit
ready device design files
Integration of Risk
Risk documentation managed through document
management activities
Fully integrated with Design Controls in ISO 14971
compliant manner
Reduced patient and business risk; risk processes
that are compliance ready and audit proven
Design Reviews
Planned and documented offline with design
review artifacts managed as controlled documents
Online – simple to plan, assign, & manage; design
review artifacts automatically generated
Accelerated product development timelines,
reduced likelihood of design details or
documentation negatively impacting an audit
Closed-Loop Traceability
Challenging due to lack of integrated design
controls and risk
Achieved through integrated Design Controls,
Risk, fully traceable workflows and LinkAnything
capabilities
Enables closed-loop digital traceability between
design, risk, and post-market surveillance data
needed to stay competitive in the coming decade
Ease of Use
Configuration-heavy nature leads to watered
down user experience that is also costly to train
end users on
Simple to implement and easy for team members
to learn and use
Time and cost savings associated with training;
higher adoption rates positively impact company’s
culture of quality
System Validation
Internal resources required. Validation templates
are incremental upcharges; may not be included
at no charge with each new update/release
Part 11 compliant software validation package
(IQ/OQ/PQ) included with each update/release
Simplifies adoption of new features and software
capabilities as they are released
Advisory Services
Software only; lack of expertise in medical device
industry
Medical Device Guru Advisory
Support Packages & Partner Network
Gain insights that span QA/RA and technology
systems from experienced medical device
professionals that increase ability to navigate
your QMS alongside industry best practices
System Scalability
Can scale for core quality processes with
costly configuration and ongoing validation;
typically fall short in ability to scale for product
development needs
Scales globally with ease for both quality and
product development activities
QMS supports companies' efforts to scale
processes rather than acting as a bottleneck

51. FDA device-surveillance
inspections require formal action
due to quality system failures
50% 50%
MCKINSEY & COMPANY: CAPTURING THE VALUE
OF GOOD QUALITY IN MEDICAL DEVICES
GREENLIGHT GURU: STATE OF MEDICAL DEVICE PRODUCT
DEVELOPMENT AND QUALITY MANAGEMENT 2020 REPORT
Medical device companies still
use traditional paper or electronic
document-based “paperless”
systems to manage quality
COINCIDENCE?

52. Enabling the Shift to Full Lifecycle Quality Traceability

53. INCREASE VISIBILITY
AND CONTROL.
MAKE THE SHIFT TO
TRUE QUALITY.
REDUCE THE UNKNOWNS
AND YOUR RISK.

54. Premarket Quality Management Software
Postmarket Quality Management Software
Quality Management Experts

55. • Bring safer, high-quality
medical devices to market
faster.
• Ensure compliance and
gain visibility across entire
product development
lifecycle.
• Manage documents,
records and SOPs.
• Route for electronic
review and approval.
• Document design control
objects easily.
MDQMS Premarket Software Capabilities
• Create and update your
traceability matrix quickly.
• Link complex
configurations and attach
related documents with a
single click.
• Ensure full traceability
and auditability.
• Visualize relationships
between risks and
requirements
automatically.
• Identify, mitigate, and
prevent risks early.
MULTI-LEVEL DESIGN CONTROL | RISK MANAGEMENT | ADVANCED DOCUMENT MANAGEMENT

56. Built-in controls that align with 21 CFR Part 820 and
ISO 13485:2016
MDQMS FULL PLATFORM CAPABILITIES
Flexible review & approval workflows with Part 11
compliant e-Signatures
Fully integrated risk aligned to ISO 14971
LinkAnything drives full lifecycle traceability
Zero effort system validation
Drive collaboration with task management, comments, and
notifications

57. Medical Device Experts
Jesseca Lyons
• Has worked with
medical device
companies in
launching devices
from initial concept
through
manufacturing and
supply chain
• Self professed design
controls junkie
• Can’t say no to a
good book or dark
chocolate
Jon Speer
• Loves helping
companies keep
product
development, quality,
and regulatory in
balance
• Has implemented
scalable, right-sized
QMS processes with
hundreds of medical
device companies
• Likes baseball so
much that he once
coached a high
school varsity team
Tom Rish
• Extensive experience
in medical device
product development
at Fortune 500 and
small start-ups
• Knows what it takes
to get a QMS ready
and through ISO
13485:2016
certification because
he’s done it
• Has traced his
genealogy to
England. We think he
may own part of a
castle
Taylor Brown
• ISO 13485 Lead
Auditor
• Prior to GG,
responsible for
maintaining medical
device quality
systems over 40 sites
• A real pro at training
customers on GG
workflows and
getting them going --
FAST
• Prefers riding a
bicycle so much that
she teaches spinning
classes several
evenings.
Barret Mueller
• Has worked with
medical device
companies in
launching devices
from initial concept
through
manufacturing and
supply chain
• Self professed design
controls junkie
• Can’t say no to a
good book or dark
chocolate
Wade Schroeder
• Electrical engineer by
trade.
• Risk management
enthusiast.
• Enjoys helping
companies develop
design processes that
their team can be proud
of.
• Loves helping
customers implement a
culture of true quality
within their team.

58. THANK YOU! QUESTIONS?
Jon.Speer@Greenlight.Guru
Jon Speer
Founder and VP of QA/RA of Greenlight Guru
PRESENTATION EXCLUSIVE:
Visit
https://www.greenlight.guru/QMS-musts-startups-offer
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