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Medical Device Standards

Across industries, standards are an important way to safeguard product conformity while simultaneously harmonizing requirements both nationally and internationally. There is probably no other industry in which product conformity is as crucial as in the design and manufacture of medical devices. With significant expertise in the medical device manufacturing sector, NQA is ideally placed to assist clients in implementing ISO 13485 and other medical device manufacturing standards.

The Medical Device Industry

The medical device industry is responsible for the design and manufacturing of a wide range of products used to diagnose and treat illnesses and improve health in patients. Products range from imaging equipment to artificial joints and other implants. Top players in the medical device industry bring in billions of dollars in revenue every year.

Because medical devices are essential tools for healthcare, and because these devices have direct impacts on public health and quality of life, their safety is imperative. To create desirable outcomes for all parties and prevent device recalls, companies must follow relevant medical device manufacturing standards. These standards help ensure that a manufacturing or design process can consistently produce the quality required to serve patients and healthcare professionals.
medical device standards

Medical Device Standards Supported By NQA

Several management standards are applicable to medical device manufacturing. Read on for a brief overview of the most relevant, as well as information about the role NQA can play in getting your organization certified.

medical device standards

The most common medical device manufacturing standards include: 

  • ISO 9001: This is the general standard for quality management. It is not industry-specific and as such can be successfully adopted by any organization that wishes to implement a more rigorous system based on a continuous improvement cycle. For medical device manufacturers, ISO 9001 engages management in the quality control process, helping make organization-wide changes that keep costs down, improve accountability, facilitate growth in a more responsible manner and simplify regulatory compliance.The most recent version of ISO 9001, published in 2015, is based on the high-level Annex SL directive, using a common vocabulary and structure that makes it easier to attain compliance with other, more specific standards.
  • ISO 13485: This is the quality management system specifically designed for medical device manufacturers. It expands on and refines the framework established by ISO 9001, with the aim of harmonising regulatory requirements. Compliance with ISO 13485 helps with overall quality control, traceability, process validation and risk management. Manufacturers that attain ISO 13485 compliance will have an easier time bringing their products to international markets. Compliance can also streamline your processes and ultimately help you run a more efficient, profitable and risk-averse operation.
  • ISO 14001: Sustainability is an important concern for all manufacturers trying to run a leaner business. Implementing an environmental management system compliant with ISO 14001 standards can help medical device manufacturers cut down on waste, conserve energy and reduce their overall carbon footprint — important benefits when working with complex global supply chains. Like ISO 9001:2015, the most recent version of ISO 14001 is based on the Annex SL structure. As a result, if you already have a certified quality management system in place, adopting ISO 14001 can be relatively straightforward. When your environmental, health and safety, and other protocols share requirements, your business is better positioned to succeed in the competitive medical device industry.
  • ISO 50001: This standard complements ISO 14001 by offering a specific standardized system for energy management. With it, medical device manufacturers can reduce their operating expenses and improve their overall energy efficiency, which can subsequently enhance their reputation and facilitate regulatory compliance.
  • OHSAS 18001 / ISO 45001: Pharmaceutical and medical device manufacturing often presents specific occupational risks, particularly when working with the advanced technology found in imaging equipment and other products. While ensuring the safety of your team is essential, it shouldn't come at the expense of productivity. OHSAS 18001 / ISO 45001 outlines requirements for occupational health and safety management systems that can be employed in the medical device industry to reduce risk and improve accountability while positioning your organization for sustainable growth. Use it to reduce accident rates and related liability issues on an ongoing basis.
  • ISO 27001: As medical devices become more sophisticated, cybersecurity is an increasing concern. The growing market for smartphone-based health-monitoring apps, as well as connected devices in the diagnostic room and operating theatre, requires proactive information security standards. Add to that the risk of your valuable intellectual property being compromised in a data breach, and it is clear to see why ISO 27001 has become a critical standard for health care and medical device manufacturers. ISO 27001 contains tools that can help you assess and manage cybersecurity risks in your organization. It is based on a set of internationally recognized best practices that are not specific to any one platform or software package. Becoming ISO 27001 certified will position you to adapt accordingly as the threats against your enterprise change and to maintain continuity in the event of a cybersecurity incident.

Our Experience

At NQA, we have extensive experience helping medical device manufacturers achieve certification. We have a worldwide network of experts who participate in standards writing and pay attention to developments in the industry, which makes us an ideal certification body to help you implement ISO 13485 and supporting standards.

So far, we've issued more than 43,000 certifications to clients of all sizes across more than 90 countries. Our clients in the medical sector include New England Biolabs, Pac-Dent International, GESUS New England, Tecomet and RR Donnelley Banta Global. We look forward to working with your organization as well.

Our Services

As an accredited certification body, NQA performs auditing for businesses in a variety of industries, including medical device manufacturing. In addition to offering ISO 9001, ISO 13485 and other medical device industry certifications, NQA also offers a wide range of services to help your organization achieve and maintain compliance. For example, we offer flexible training options to provide your team with the technical skills necessary for certification. Choose from online, classroom or in-house courses to best suit your needs.

No matter what medical device standards you need certification in, we will always work to provide you with practical advice and suggestions for improvement beyond basic compliance.
medical device compliance

Why NQA?

At NQA, we believe our clients deserve to work with a certification body that offers value and excellent service. We are passionate about providing you with the information you need to improve your products and processes and achieve compliance with industry standards. Though our approach to certification is rigorous and upholds the integrity of accredited certification, we also work to offer pragmatic support to our clients. Some of the benefits of working with NQA include:

  • Competitive pricing: We constantly monitor the industry to make sure our pricing remains competitive and fair. There are no hidden fees associated with our services, so you will always receive great value when working with NQA.
  • Responsiveness: Though we're an accredited certification body with a global reach, we retain a local attitude. This attitude enables us to respond flexibly to changes in the medical device manufacturing industry and within individual organizations.
  • Improvement focus: In addition to assessing your company's compliance, we also strive to provide practical suggestions for improvement during every audit. There is always room for growth when it comes to quality control and risk management.

Get Started Today!

Certification is an essential step for any medical device manufacturer. To receive a quote, complete the NQA online Request for Quotation form or contact us for more information today. Get all of your questions answered, choose the package that works best for you and then you’re ready to go!

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We'll give you a clear indication of the costs of gaining and maintaining certification.
Not ready yet? Call us at (800) 649-5289 or request a call back to discuss your certification requirements.