Blog

The global medical market is projected to grow at a faster rate due to increasing demand. This is mainly because of technological developments in the medical field as well as the wider prevalence of diseases among all age groups.

As consumers are relying more on advanced medical devices to recover from illnesses or live a quality life, companies need to ensure meeting their expectations by providing quality devices. Moreover, governments and medical authorities are also imposing regulations and legal obligations on the manufacturers to make sure the companies emphasize quality.

In such a context, companies should choose to achieve the ISO standards for medical devices. Here this blog briefly points out the importance of those standards and how they can benefit medical device companies.

Importance of ISO Standards for Medical Devices

There are many prominent ISO standards, starting with the key standard, ISO 13485 which is for medical device Quality Management System (QMS). Other standards that apply to medical device companies are ISO 14001 (Environmental Management System), ISO 45001 (Occupational Health and Safety), ISO 27001 (Information Security Management System), and ISO 22301 (Business Continuity Management System).

Gaining compliance with these standards will prove that your medical device company has best practices in place to deliver quality and safe devices.  They ensure that your company meets the applicable regulations and legal obligations. As a result, customers believe that your devices or products are free of risks or safety issues.

4 Ways ISO Standards will Help Your Medical Device Company

1. Process improvement and prevention of issues

A key criterion for achieving an ISO standard is driving the process of continuous improvement in your business. The standard will lead to the implementation of a strong management system that will foster communication and bring employees on the same page.
The employees will be working together through certain systematic processes and look for scopes to improve them. They will discover process inefficiencies or issues that can hamper the quality and performance of end products and prevent them. Therefore, you will be able to continuously improve your processes and deliver superior quality devices.

2. Boost customer trust and help you gain a market share

Being an ISO-certified company will create trust in your customers. They will be reassured that your devices are developed following necessary regulations, and hence, bear no risks.
Besides, corrective and preventive actions are a part of ISO standards implementation. They require you to take care of the customer complaints, analyse the causes of defects or reworks, and collect feedback from authorities. Looking at these, you decide on corrective/preventive actions and address the long-standing issues in your processes or devices. Thus, you can gain the trust of customers, grow your sales, and get a higher market share.

3. Improved engagement and performance of employees

ISO standards foster a cooperative culture in the company. The leaders/top management team strives to make improvements. They ask employees to look for ways to further drive the efficiency of their operations. They designate respective roles to employees that would help in enhancing processes and maintaining compliance with the standards. As a result, employees feel appreciated and tend to become more engaged. This will positively impact their performance.

4. Achieve recognition and credibility of your company

A key benefit that ISO standard(s) give to businesses of all types is worldwide recognition. The standards are globally recognised and accepted everywhere. They prove that your company follows best practices and regulations to deliver superior products. Thus, they will impart the credibility of your company and give you a chance to expand sales in other countries.
In other words, ISO standards will help boost your marketing by demonstrating your compliance with stringent regulations and quality practices.

5. Gain a competitive advantage in the market

ISO certifications help businesses of all types to strengthen their position in the market and achieve a competitive advantage. They will convey that your company is quality-focused so that your medical devices are preferred over the competitors’ products.
The certifications will also enhance your company’s ability to win supply contracts from big firms and healthcare service providers. When they know about your ISO standards, they will be assured about the quality and consistency of your devices. Thus, your company will have more chances or opportunities to get profitable contracts.

Summing it up!

The importance of ISO standards for medical devices is immensely felt by companies in the industry because of the strict regulations and pressing demands of customers.  Needless to say, both quality and safety are invariable concepts in this particular industry. Patients and healthcare service providers seek innovation in the devices for better utilities but at the same time need assurance of their quality and safety.

Gaining the ISO standards will help your medical device company to meet the quality and safety expectations of customers by continuously improving your processes. However, that’s not all! With the standards, you come across many associated benefits. Altogether, they make investments in ISO certifications extremely worthwhile for your company.

Need help with the certification of your medical device company? Contact our team of ISO consultants at Compliancehelp. We will work with you and help you implement a management system compliant with the ISO standard.