This document provides an overview of a webinar discussing efficient medical device product development processes that align quality, regulatory, and business needs. It emphasizes the importance of defining product requirements, understanding regulatory submissions, and selecting compliant manufacturers. Additionally, it covers post-commercialization considerations and how experts can assist in navigating the complexities of medical device development.

1. www.emmainternational.com
Medical Device Product
Development
Madison Wheeler
Quality Engineer

2. Webinar Overview
• The purpose of this webinar is to discuss the characteristics of
an efficient product development process for medical devices.
• The ultimate takeaway is that medical device product
development should incorporate Quality, Regulatory, and
Business needs in parallel.

3. Madison Wheeler
Quality Engineer
Madison.wheeler@emmainternational.com
Office: 248-987-4497
Ms. Wheeler is a Quality Engineer with experience in
technical writing, nonconforming product management,
issue evaluations, and implementing corrective and
preventative actions in the pharmaceuticals and medical
device industries. She has experience cross-functionally
between R&D, lean manufacturing operations, and RA
compliance. Ms. Wheeler also has academic and work
experience with human health-risk engineering controls,
physiological biophysics, and clinical research.
Ms. Wheeler holds a Bachelor of Science of Biosystems
Engineering with a concentration in Biomedical
Engineering from Michigan State University.
3

4. Leaders in Compliance
Consulting and
Enterprise Quality
Management Software
• EMMA International Consulting Group, Inc. is a global leader in
management consulting services and headquartered in
Farmington Hills, MI.

5. Product Development Overview
Engineering
Regulatory
Assessment
Manufacturing
Regulatory
Submission
Commercialization

6. Product Development Overview
Engineering
Regulatory
Assessment
Manufacturing
Regulatory
Submission
Commercialization

7. Regulatory Assessment
• Will need to define the Product Requirements Document
(PRD) and the Marketing Requirements Document (MRD)
• Basic specs of the device
• Intended Use
• Market Population
• Plan for FDA Submission
• What classification your device falls under
• Predicate devices
• What type of pre-market submission your device requires

8. Product Requirements:
• Will define device’s
intended use, features,
and functionality
• Requirements should be
specific and measurable
• Will tie into design
controls and User Needs
traceability[1]
Regulatory Assessment: Developing Requirements
This Photo by Unknown Author is licensed under CC BY-SA-NC

9. Regulatory Assessment: Developing Requirements
Marketing Requirements:
• Regulatory and business
need
• Why is your device
needed?
• Target user population
• You want to develop the
right product for the right
users
This Photo by Unknown Author is licensed under CC BY

10. Regulatory Assessment: Planning for FDA Submission
• Determine what premarket
submission type, if any, is required
for your device
• 510(k) (Premarket Notification)
• PMA (Premarket Approval)
• De Novo Classification Request
• Determine what requirements your
device will have to comply with[2]
• Design Controls
• Clinical Testing
This Photo by Unknown Author is licensed under CC BY-SA-NC

11. Manufacturing
• You want to find a manufacturer
that is compliant to the regulatory
and quality requirements for your
medical device
• Exercise caution when picking a
manufacturer
• Pick a manufacturer who is
flexible to meet your needs and
will ensure compliance
• Manufacturer’s are subject to FDA
inspections
This Photo by Unknown Author is licensed under CC BY-SA-NC

12. Manufacturing:Various Requirements
• There are several different types
of assembly and environments
your device may require
• ISO 14644-1 Cleanrooms and
associated controlled
environments[3]
• Overmolding for medical devices
• Medical device assembly
precision
• A robust QMS will need to be
built for device manufacturing

13. Regulatory Submission
• It is important to understand why type of submission is
necessary for your device
• Be prepared to answer follow-up questions from the
FDA
• Understand all the logistical requirements for
submitting
• Have a realistic plan for timelines

14. Regulatory Submission: Acceptance Review
The FDA can
Refuse-To-Accept
(RTA) any
submission that
doesn’t meet
specific
requirements
There are
different
requirements
depending on
different
classifications and
submissions
The purpose is to
allow the agency to
focus resources for
substantive review
on complete and
quality submissions
only

15. Regulatory Submission: Acceptance Review
• “Is the Submission with the
appropriate Center?”
• “Submission contains a Table of
Contents”
• “Each Section is Labeled”
• File type is also important (PDF vs.
Word)
• Each file must follow a specific
naming convention
• 180 day deadline for re-
submission[4]
This Photo by Unknown Author is licensed under CC BY-SA

16. Commercialization
• There are still many things to consider, even after
your device is on the market:
• Maintaining a robust QMS
• Additional regulatory submissions
• Expanding into different
markets
• EU MDR
• Medical Device Single
Audit Program (MDSAP)

17. Commercialization
• MDSAP: Australia, Brazil, Canada,
Japan, U.S.
• Harmonized to 13485: 2016[5]
• More robust than 21 CFR 820
• More ties to ISO 14971 (Risk
Management)[6]

18. [7]

19. So what does this mean for you?
• Product development
for your medical device
can be confusing and
time-consuming
• Experts (like EMMA!)
can help you make
sense of it all and ensure
compliance

20. Farmington Hills, MI:
Headquarters
27600 Farmington Rd., Suite 100
Farmington Hills, MI 48334
Phone (248) 987-4497

21. References
1 Church, Voler Systems (February 2018) Developing Product Requirements for Medical Devices retrieved from:
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/MedicalDeviceQualityandCompliance/ucm590419.htm
2 FDA (December 2019) How to Study and Market Your Device retrieved from: https://www.fda.gov/medical-devices/device-
advice-comprehensive-regulatory-assistance/how-study-and-market-your-device
3 ISO (December 2015) ISO 14644-1:2015 Cleanrooms and associated controlled environments – Part 1: Classification of air
cleanliness by particle concentration retrieved from: https://www.iso.org/standard/53394.html
4 FDA (September 2019) Refuse to Accept Policy for 510(k)s retrieved from: https://www.fda.gov/media/83888/download
5 FDA (December 2018) FDA Update Transition to ISO 13485:2016 retrieved from: https://www.fda.gov/media/123488/download
6 BSI Group (n.d.) Medical Device Single Audit Program (MDSAP) retrieved from: https://www.bsigroup.com/en-GB/medical-
devices/our-services/Medical-Device-Single-Audit-Program/
7 Mulero (May 2018) MDSAP Sees Site Participation Increase retrieved from: https://www.raps.org/news-and-articles/news-
articles/2018/5/mdsap-sees-site-participation-increase