The document outlines the importance of rigorous design and development in medical device manufacturing to meet quality expectations and prevent customer complaints and device failures. It emphasizes the need for compliance with regulations like ISO 13485:2016 and 21 CFR Part 820, highlighting that poor design is a major cause of product recalls and safety issues. Key stages in the design process include design control, verification, and validation to ensure safety and efficacy, especially for drug-device combination products.

1. Medical Device Design
and Development
https://www.operonstrategist.com/medical-device-design-development/

2. Medical Device Design and Development and also Drug-device
combination product plays a vital role in making the medical
device which meets the quality expectations at par and may not
lead to the customer complaints and failure in the market .The
route cause of most of the customer complaints, recalls , device
failures is the poor design and development activity. Any
product failure is a major non-compliance & may result in
adverse events affecting users.

3. The Stages Include in Medical Device
Design And Development Process:
During the design and development stage of the medical
device design process, we assist various medical device
manufacturing industries to ensure that appropriate steps are
taken to meet regulatory compliances of the medical device
design and development.

4. The medical device design and
development services following:
 Drug and Device Combination Products
 Medical Device Design Control

5. Drug and Device Combination Products:
Each manufacturer of Drug-Device combination product (e.g. Drug, device
combination products like prefilled syringes, applicators of the tropical products)
shall have adequate design and development activity done so as to prove the
adequacy of the safety and efficacy of the product.

6. The design and development activity is the
systematic methodology, which establishes the
proper design and development of the products.
Many of the customer complaints and 483’s in
case of the medical devices or combination
devices are contributed to the improper of the
design and development control activity. The
design and development requirements of the
product are described in ISO 13485: 2016and 21
CFR Part 820 also.

7. Examples Of Combination Products:
 Intraoperative drug + Detecting Device
 In-vitro diagnostic test to select patients for a specific biological product therapy
 Photosensitizing drug and activating light source
 Drug-eluting coronary stent
 Prefilled drug/biological delivery system
 Metered dose inhalers
 Drug/biological product packaged with a delivery device.

8. Medical Device Design Control
After conceptualizi
ng a new medical
device, the next
step in its product
advancement is
the design.
Verification Medical
Device
Design
Output
Design
Process
Design
Input
Validation
Review
User
Needs

9. Medical Device Design Control is the most
important stage in the advancement of
a medical device since a defective plan may
prompt it being inadequate or dangerous (that
is, not affirmed or cleared by the administrative
organization). At the design stage, an
outline control process should be started and
actualized as a feature of the quality system
requirement.

10. Thank You.
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