Medical Devices

Medical Devices

Make sure that the manufacturing or design of medical devices is consistent and meets the needs of patients and healthcare providers

Medical Devices

Make sure that the manufacturing or design of medical devices is consistent and meets the needs of patients and healthcare providers

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, IRCLASS 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 Certified by IRQS

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 IRQS can play in getting your organization certified.

The most common medical device manufacturing standards include:

ISO 9001 Quality Management Systems

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 Medical Devices

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 Environmental Management Systems

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 Energy Management Systems

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.

ISO 45001 Occupational Health & Safety Management Systems

Along with offering reliable products and services, automotive manufacturers must constantly strive to provide their workers and visitors with a safe and healthy business environment. With the ultimate goal of providing businesses with a framework for controlling and eliminating factors that can lead to illness, injuries and — in worst-case scenarios — death, obtaining ISO 45001 Health and Safety certification is a prudent move for any organization’s senior management to support.

ISO 27001 Information Security Management Systems

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.

Get Started Today!

Certification is an essential step for any medical device manufacturer. To receive a quote, complete the IRQS 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!

Ready To Get Certified?

Demonstrate your credibility and commitment to quality