Quality Management in Medical Devices industry

Cost of poor Quality:
The medical device industry has in the recent years been affected by several product quality incidents. These incidents have impacted patient health, but also caught media attention and caused the negative brand image and investor relations.  The medical device product development life cycle operates under complex regulations and cost to compliance is critical.

Quality Management is significant for the industry in order to meet international and national regulations, but also to meet and exceed customers’ expectation. If the appropriate quality management system is not fully implemented, including a proactive quality mindset throughout the company several issues can arise. One such issue is the cost of poor quality. The illustrative picture below of the quality iceberg can be a good starting point to understand the issue: The visible part of the cost of poor quality is defects, rework or scrap. Below the surface causes such as revenue loss to sales, culture, behavior and attitudes, loss reputation in the market and customer dissatisfaction is less visible.


Quality System Regulations:

Working in the medical device manufacturing industry requires knowledge of different quality methods and regulations. In the list below, we will list some areas of focus:

1.Quality System Regulation and Good Manufacturing Practices

The Food and Drug Administration’s (FDA) regulates a broad range of medical devices before they reach the marketplace. They assure that medical device available in the United States is safe and effective.

There are regulations and practices in place in order for manufactures to establish and follow quality systems for ensuring that their products met applicable requirements and specifications. The Good Manufacturing Practices for Medical devices are codified under Code of Federal Regulations Title 21- PART 820 QUALITY SYSTEM REGULATION

Read more on Quality System Regulation – Quality System (QS) Regulation/Medical Device Good Manufacturing Practices

The content of Medical Device GMP can be divided into different sub-parts:

Subpart A–General Provisions

Subpart B–Quality System Requirements

Subpart C–Design Controls

Subpart D–Document Controls

Subpart E–Purchasing Controls

Subpart F–Identification and Traceability

Subpart G–Production and Process Controls

Subpart H–Acceptance Activities

Subpart I–Nonconforming Product

Subpart J–Corrective and Preventive Action

Subpart K–Labeling and Packaging Control

Subpart L–Handling, Storage, Distribution, and Installation

Subpart M–Records

Subpart N–Servicing

Subpart O–Statistical Techniques

Read this guidance presented by the Food and Drug Administration’s (FDA’s) – Guidance for Industry

2.Unique Device Identification

The supply chain of medical devices is also complex with regulation affecting packaging, distribution and handling. There are several requirements on medical device traceability.

FDA requires that most medical devices distributed in the United States carry a unique device identifier. There are also requirement within the EU and they are listed under the EU MDD Medical Device Regulation.

The next steps:
In today’s competitive business cost of poor quality can be fatal for companies operating in the medical device industry. In this articles reading list, we will recommend three readings for professionals in this industry in order to get a better understanding of cost of poor quality.

1. The Business Case for Medical Device Quality
A study investigating the financial impact of cost of poor quality (Fuhr, George and Pai,2013).
2. Preparing for the future: The new European Union Medical Device Regulation
An introduction into the new European regulations. The report is conducted by the multinational professional services company Deloitte.
3. Implementing ISO 13485 Medical Devices Quality Management System
A seminar describing how to implement and work with ISO 13485 Quality Management System (Evans, 2013)


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