Despite ever-changing and increasingly complex medical device regulations, many companies have built their compliance systems on risky paper-based quality systems or legacy, general-purpose software not built for med device. You can do better. Inefficient systems increase your risk of noncompliance and increase your development time. That translates into missed sales opportunities and patients waiting longer for your new medical technologies. So we’ll show you a modern, purpose-built software that ensures compliance with all the latest regulations to free up your engineers’ time, reduce risk, time to market, and help you pass audits with flying colors. • Step-by-step instructions on how to implement and maintain an audit-ready QMS leveraging Jon’s S.M.A.R.T. quality management philosophy • How to accelerate product development efforts — from napkin idea to 510(k) clearance to market release months or years quicker • How to manage risk to drive the safety and quality of products and processes through QMS per ISO 13485:2016 & 21 CFR Part 820 • How to change their company’s focus from simply meeting regulations to building quality into their processes as a differentiator • How to understand and stay ahead of the FDA and EU changing quality regulations as leaders instead of followers This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.

1. How to Implement and Maintain
an Audit-Ready QMS Leveraging
Technology

2. ABOUT THE PRESENTER
Greenlight Guru produces beautifully
simple quality, design control and risk
management software exclusively for
medical device companies.
Jon Speer
Founder and VP of QA/RA of Greenlight Guru
§ 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

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. WHAT THE INDUSTRY IS SAYING
Medical device manufacturers can reduce costs and increase
their profits by focusing on quality measures during medical
device design and production. This quality improvement
approach pays dividends in customer satisfaction and
provides significant competitive advantages.”
FDA’s Case for Quality
“A focus on quality can have a
significant impact on bottom line,
reputation, and share price.”
“$20 million might not seem like a lot of money to
you, but if you get a $20 million haircut on your
valuation because your design controls and quality
system aren't up to speed, I guarantee you that's
going to hurt.”
“The medical device industry’s direct cost of quality of
approximately 6.8 to 9.4 percent of industry sales, or
$26 billion to $36 billion annually. For a company
going from average to good, the opportunity is 3% -
4% of revenues.”
Ronny Bracken, CEO
18 Year CR Bard Strategy and
R&D Executive

6. Higher employee turnover rates at medical device
companies that do not invest in and prioritize quality191%
⅔
of executives believe Cost of Quality is essential to
excel at for their companies to stay competitive in an
era of rapid globalization

7. Some people look at the quality system as a burden,
as something they must do …
Today I will challenge you to look at it in a different way.

8. Give you step-by-step instructions on how to
implement and maintain an audit-ready QMS
leveraging my S.M.A.R.T. quality management
philosophy
1
GOALS FOR TODAY

9. Show you how to accelerate product
development and manage risk to ensure safety
throughout the total product lifecycle
2
GOALS FOR TODAY

10. Help you shift your company’s focus from
compliance-only to TRUE QUALITY through
processes that serve as a competitive
differentiator
3
GOALS FOR TODAY

11. Requires a risk-based approach to quality
throughout product lifecycle
EU MDR establishes stringent controls and
quality traceability for any devices sold in the EU
‘Super Office’ to drive visibility into device safety
and effectiveness throughout device lifecycle
Audit reports and non-conformities shared
with all participating countries: United States,
Canada, Japan, Australia, and Brazil.

12. MEDICAL DEVICE QMS OVERVIEW

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

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

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

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

17. 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

18. • Opportunity for better integration across entire QMS
• Improved efficiency
• Better alignment with global regulatory bodies
• Medical devices that are safer and more effective
Audit-Ready QMS Processes

19. The Costs of Poor Quality
• Product & process quality suffers
• Not integrating risk-based approaches into your QMS
• QMS wrong-size & complicated
• Out of sync with regulatory expectations and best practices
• Lack of competitive advantage

20. HOW TO IMPLEMENT AND
MAINTAIN AN AUDIT-READY QMS
USING THE
S.M.A.R.T. METHODOLOGY

21. SCOPE
Quality
Planning
TRACK
QMS
Post-Market
MAKE
QMS during
Product
Development
APPROVE
QMS during
Transfer to
Manufacturing
RELEASE
QMS during
Go-to-Market
S.M.A.R.T
Methodology for
Audit-Ready
QMS

22. Scope Phase – Quality Planning of QMS Processes
• Device classification
• Gap analysis
• Quality and regulatory plan
• Project scope

23. • Design Controls
• Risk Management
• Document Control & Records Management
• Supplier Management
Make Phase – QMS Processes during Product
Development

24. • Training
• Purchasing
• Device Master Record (DMR)
• Production & Process Controls
• Labeling & Packaging
• Receiving, Incoming, In-Process,
& Final Inspection
• Identification & Traceability (DHR)
• Change Management
• Nonconforming Material
• CAPA
• Management Responsibility
Approve Phase – QMS Processes during Transfer to
Manufacturing

25. • Process Validation
• Software Validation
• Calibration
• Preventive Maintenance
• Handling, Storage, Distribution, &
Installation
• Servicing
• Complaint Handling
• Adverse Event Reporting / MDR
• Corrections & Removals
• Customer Feedback
• Analysis of Data
• Quality Manual
Release Phase – QMS Processes during Go to
Market

26. • Internal Auditing
• Monitoring Effectiveness of QMS
• Monitoring Products
• Focus on Total Lifecycle Risk Management
Track Phase – QMS Processes during Post-Market

27. Leverage the best …
1. People
2. Processes
3. Technology
A Medical Device QMS Must …

28. Audit-Ready QMS Implementation Best Practices
Primary Missions:
1. Aligns with applicable regulations
2. Describes the processes and practices within
your company

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

30. YOUR OPTIONS FOR A QMS…

31. • 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 Systems

32. • 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

34. 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

35. 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

36. 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?

37. Enabling the Shift to Full Lifecycle Quality Traceability

38. Market leading companies innovate with quality

39. INCREASE VISIBILITY
AND CONTROL.
SHIFT FROM JUST
COMPLIANCE TO TRUE
QUALITY.
REDUCE THE UNKNOWNS
AND YOUR RISK.

40. Premarket Quality Management Software
Postmarket Quality Management Software
Quality Management Experts

41. • Advance success of true
quality medical device.
• Stay ahead of changes,
improve continuously,
and save time.
• Manage CAPAs and
connected processes
• Full visibility into quality
issue trends for early
mitigation
• Streamlined customer
feedback and complaint
process.
MDQMS Postmarket Software Capabilities
• Reduce nonconformance
cycle times and risks
associated.
• Conduct internal, external
and supplier audits with
ease.
• Link any item associated
with premarket and
postmarket processes
• Assign training, set due
dates, and keep track of
tasks to ensure training
completion.
• Ensure full traceability and
auditability throughout.
CAPA MANAGEMENT | CHANGE MANAGEMENT | COMPLAINT MANAGEMENT
AUDIT MANAGEMENT | NONCONFORMANCE MANAGEMENT | TRAINING MANAGEMENT

42. Built-in controls that align with 21 CFR Part 820 and
ISO 13485:2016
MDQMS 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

43. 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.

44. THANK YOU! QUESTIONS?
Jon Speer
Founder and VP of QA/RA of Greenlight Guru
Jon.Speer@Greenlight.Guru
PRESENTATION EXCLUSIVE OFFER:
Visit
https://www.greenlight.guru/audit-ready-QMS-offer
to access your FREE download!