How to Check Manufacturing Quality Standards When Buying a Medical Device

When you’re investing your money in new medical devices, you’ll want to have complete confidence in the manufacturing standards. After all, any imperfections or faults in these products could have serious consequences for users. But, given that all companies have a clear incentive for suggesting their goods are high quality, how can you tell if they’re really telling the truth?

Fortunately, there are ways to cut through any marketing spin and get a clearer picture concerning the standard of these devices – and this brief guide talks you through the basics.

Blood pressure gauging device

See if it conforms to ISO standards

One effective way to assess the quality of a particular product is to check it if conforms to criteria set out by the International Organisation for Standardisation (ISO). These standards represent a comprehensive management system for the design and production of a range of devices.

The ISO is the world’s largest developer of voluntary international standards and it has published over 19,500 of them covering nearly every industry, more than 12,000 of which focus on healthcare. These standards denote world-class specifications for systems, products and services to help ensure safety, quality and efficiency.

Although they are not compulsory for all medical products, many companies seek to conform to them as they provide a useful way of determining quality. For example, to reassure its customers, orthopaedic bed specialists Adjustamatic adheres to the requirements of ISO 9001:2008  and ISO 13485:2003. The first of these standards contains requirements for a suitable quality management system and it is relevant to all organisations, regardless of the type of product they provide. Meanwhile, the second specifies requirements for a quality management system for businesses that provide medical devices and related services.

By choosing products from companies that are ISO accredited like this, you can give yourself greater peace of mind.

ISO 9001 certification

Look for a CE mark

A CE mark is another clear indication of quality. It shows that products are fit for their intended purposes and conform to the relevant European Union safety laws.

Manufacturers can only place this logo on products if they meet all the criteria in the relevant directive. In order to demonstrate that their goods adhere to these standards, producers must carry out strictly controlled conformity assessments.

Check out user reviews

As well as checking for specific benchmarks of manufacturing quality like ISO certification and a CE mark, it pays off to read a selection of user reviews before committing to making a purchase. By reading the thoughts of existing users, you can gain insights into the standard of medical devices and identify potential advantages and disadvantages that you may otherwise have overlooked. The more reviews you can find, the better.

Reading a range of opinions will help you to build up an accurate and detailed picture.

By making sure you know the facts when it comes to quality standards, looking out for the relevant accreditations and doing plenty of research online, you can reduce the risk that you’ll purchase substandard medical devices. It may take a little time and effort to get clued up, but this could be a worthwhile investment if it stops you making potentially costly mistakes.