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Quality is never an accident. It is always the result of intelligent effort. – John Ruskin
Quality is a key trait of all successful medical device firms. Quality & Compliance related parameters not only drive operational and financial efficiency but also act as competitive differentiators.
Customers demand it.
Regulators require it.
Competition compels it
More than any segment, medical device manufacturers need to ensure the quality of their products because they deal with human health. The accuracy and efficiency of the devices could well be a matter of life and death.

That’s not all. Here are a few more reasons why you must focus on implementing quality practices if you are a medical device manufacturer:

  • To reduce manufacturing costs
  • To improve productivity and efficiency
  • To increase customer satisfaction
  • To increase profitability
  • To beat competition
  • To protect your reputation and build on relationships

There are several examples of how quality-related errors have costed medical device firms badly. For example, a medical device firm had to recall its Flo Humidification Systems due to malfunction with the potential danger of water entering the respiratory airway, a life-threatening risk in some cases.

In another instance, non-invasive and invasive ventilators from one manufacturer were recalled due to sound alarm failure, again a mission-critical risk that could have been prevented with a more robust quality process in place.
Implementing quality practices is essential for the manufacturer in more ways than one. An automated, enterprise-wide quality management system such as the one provided by ComplianceQuest can provide deep insights that can go beyond and help increase the efficiency and effectiveness of the medical device manufacturer’s operations and processes.

We believe a successful implementation of a QMS in the medical device sector requires a simple 7-Step approach

  • Step 1: Understand the regulatory landscape
  • Step 2: Design your Quality & Compliance Process and automate with an EQMS
  • Step 3: Benchmark against industry best practices
  • Step 4: Design standard operating procedures
  • Step 5: Create a Master Quality & Regulatory checklist
  • Step 6: Quality Analytics to derive insights from Quality Data
  • Step 7: Continuous Improvement

Step 1: Get the Basics Right: Understand the Regulatory Landscape for Medical Device Quality

Just between January and March of 2020, there were 20 recalls of medical devices due to non-compliance and improper functioning of the products. It reiterates the fact that the regulatory landscape is becoming very stringent in demanding compliance to ensure safety. It addresses not just the quality of the end product but the entire process followed from “design to customer service”. No defect is being overlooked and the product immediately recalled if it does not meet specifications.

Without doubt, this can have serious revenue implications for the manufacturer. In addition, it can also cast aspersions on their reputation with serious repercussions. For instance, according to a McKinsey report, at least one company saw a 10 per cent drop in share price due to a single, major quality event such as a major product recall.

A 2017 report shows that the cost of quality is approximately 6.8 to 9.4 per cent of industry sales. Considering the annual sales of the industry was $380 billion, this amounts to $26 billion to $36 billion annually. Getting the quality process right, on the other hand, costs much lesser, while also having second and third order positive effects on the enterprise brand.
Here we highlight all key regulatory frameworks and the compliance landscape:

FDA 21 CFR Part 11
Part 11 of Title 21 of the Code of Federal Regulations applies to the creation, modification, maintenance, archival, retrieval or transmission of electronic records with proper authentication and authorization. The documents, referred here encompass textual content, images, videos and audio files, and include:

  • Release and test protocols
  • Process and work instructions
  • Design drawings, software architecture documentation
  • Specifications, request documents
  • Records, e.g. production records
  • Review protocols

The regulation also covers the nature of digital signatures used and defines identification codes and passwords.

FDA Software Validation
Following the recall of 3,140 medical device recalls, where 242 of them (7.7%) were because of software failures, and 192 (or 79%) of that was because of software defects, FDA made software validation mandatory. Whether the software is a component of the medical device, used in the manufacturing process or the medical device itself, it needs to conform to applicable design control provisions. This is to ensure their accuracy, reliability, consistency, performance as intended and the ability to discern invalid or altered records. Early this year, system infusion pumps were recalled due to software and system errors, which could have been avoided with a proper software validation process.

ISO 13485
This International Standard covers every stage of the life-cycle of a medical device from design to development, production, storage, distribution, installation, servicing and final decommissioning and disposal of medical devices. It is also applicable to suppliers or other external parties involved in any stage of the manufacturing process. Certification is optional but can be beneficial. The standard undergoes revision every five years, with the latest revision focusing on risk management and risk-based decision making.

EU’s MDR and IVDR
The European Union’s revised Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) place greater demand on manufacturers to significantly change their product development, data reporting and quality assurance processes.

It addresses classification of medical devices based on risk assessment. New products will need to be certified accordingly while the older ones in the market will have to be recertified based on new norms.

MDSAP for Reducing Audit Costs

The Medical Device Single Audit Program (MDSAP) allows a single regulatory audit of a medical device manufacturer’s quality management system and is an aggregation of the requirements of the regulatory jurisdictions of Australia, Brazil, Canada, Japan and the United States. This aims to minimize the regulatory burden on the industry as well as on regulatory resources while aligning regulatory approaches across the globe, unifying technical requirements based on international standards and best practices.

For device manufacturers who cater to global markets, being part of MDSAP, which is voluntary, will prove to be cost effective. But still, since Europe is not a part of that, and catering to the different regulatory requirements will mean understanding the variations and conforming, medical device manufacturers face the challenge of coping. This adds the pressure of hiring resources with skills and capabilities, which is both costly and takes the management time away from their core business to focus on compliance issues.

Broadly speaking, to be able to successfully manage the varying demands of the different stakeholders, the organization needs to be on its toes always. Sometimes, it can be a matter of fire-fighting rather than introducing proactive measures. Proactive responses that integrate with the business plans is possible by the implementation of a well-planned out quality and compliance process that is aligned to the organization’s maturity level.

Once there is clarity on regulatory requirements, quality leaders in the medical device ecosystem must gear up to automate their QMS workflow with a cloud-based EQMS solution. Digital transformation and automation of the quality management system is an absolute “must have” in today’s context.

In this Whitepaper titled “A 7-Step Guide to Quality & Compliance for Medical Devices Companies” we share in great detail the other six steps. Click here to download this paper.

At ComplianceQuest, we’ve helped over 100+ medical device manufacturers automate their EQMS process with a flexible and scalable solution. Our platform is elastic to serve firms of various sizes from Fortune 500 companies to start-ups and mid-size medical device companies.

Write to [email protected] to request for a demo.

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