Design controls for

medical device
companies
Vigneshwaran Mani
You have an idea for a new medical
device. Now what?
• In the US, medical devices are regulated by FDA.
• In EU, European competent authority
• In Canada, Health Canada
• In Australia, Therapeutics Goods Administration (TGA)

• These agencies have defined rules and regulations that the developers and manufacturers must
follow, before the products are sold in their respective marketplace.
• These regulations are also known as Design Controls
What is Quality system?
A medical device company has to establish a quality system.
• A quality system: a set of processes and procedures you define and
implement to describe how your company addresses medical device
regulations, including design controls.
• FDA defines the rules in 21CFR Part 820.
• If you plan to go to market in the US, there regulations must be followed.
• In the Europe, medical device companies choose to implement a quality
system and have ISO 13485:2016 to satisfy EU needs.
• Canada, same as above and also Canadian Medical Devices Conformity
assessment system (CMDCAS).
• Good news: FDA 21CFR Part 820 and ISO 13485 are very similar regarding
design controls. “One size fits all”
Build your quality system as you go
(For startups)
• FDA regulations and ISO requirements that do apply to you, even if you are
pre-market

• There are at least 4 parts of a quality system that you need in place:

1. Design Controls

2. Risk Management

3. Document control and records management

4. Supplier management
Bootstrapping a QMS for startups
• Don’t need to spend too much time implementing a robust quality system.

• You need to be focused on product development.

• Make sure you always keep your quality system in mind from the beginning.
What are design controls
Why design controls even matter and how they will help you during
your medical device product development.

• It is important that you design and develop a medical device that is safe.

• Regulating agencies such as FDA, EU, Health Canada will want some
assurances that your medical devices is safe before you bring product to
market.

• That is real essence of design controls, Proof that you have designed a
safe product that meets user needs and requirements.

• Design controls in FDA is presented in CFR 820.30 (Code of Federal

regulations where the topic is addressed)

• ISO13485 (Section 7.3 Design and Development)

 Comparison of FDA and ISO
regarding Design and Development
Design controls FDA 820.30
(a) General
(b) Design and development planning
(c) Design input
(d) Design output
(e) Design review
(f) Design verifications
(g) Design validation
(h) Design transfer
(i) Design changes
(j) Design history file
Design & Development ISO 13485:2016
7.3.1 General
7.3.2 Design and development planning
7.3.3 Design and development inputs
7.3.4 Design and development outputs
7.3.5 Design and development review
7.3.6 Design and development verification
7.3.7 Design and development validation
7.3.8 Design and development transfer
7.3.9 Control of design and development changes
7.3.10 Design and development files

There is consistency regarding Design Controls between FDA regulations and ISO requirements
Expectation from FDA/ISO
• Regulating bodies expect you to keep documentation and records throughout
the product development process.

• The Design history file is a great place to keep all your design controls
“evidence”.
 Importance of traceability
• An industry beast-practice is to construct a traceability matrix to show the linkages and
relationship between

1. User needs

2. Design inputs (Customer requirements)

3. Design outputs (Product requirements and specifications)

4. Design verification (Establishing conformance of design outputs to design inputs)

5. Design validation (Establishing conformance that final product meets user needs)

• Initially companies use tools like Excel or google docs during early months of product
development.

• Keep updating and maintain a traceability matrix.

• More matured companies use a software solution built to specifically meet the unique
regulatory needs of medical device company.