Why do MedTech and medical device startups need ISO 13485 certified quality management systems?
Now is an extremely exciting time to be a medical device or IVD startup. With technological advancements taking place across the globe and innovation sparking throughout the MedTech industry, bringing your healthcare invention to life has never looked so thrilling!
It’s not all about award-winning technology and groundbreaking innovation though. Medical device and IVD startups need to be mindful of the important role that a robust quality management system plays in the safety of the product and its success in the marketplace. The majority of medical device and IVD companies require a QMS, and its complexity depends on the classification of the device you are producing.
Quality management systems (QMS) are structured systems that cover the product lifecycle, from design and manufacturing through to risk management, complaint handling, and product distribution. The quality management system standard followed by companies selling in Europe, Canada, Australia, and other markets is called ISO 13485. Most medical device and IVD companies use it to ensure compliance with the QMS requirements of their national medical device regulations.
ISO 13485 is the industry’s optimal medical device standard, which makes sure that all medical devices meet customer needs and the proper regulatory compliance laws. By having the ISO 13485 certification in place, your company can offer a guarantee of safety to your employees, customers and patients across the world.
If you’re a startup, what is the best way to build and implement an ISO 13485 standard QMS? Here are the most common options to choose from.
Hire a QMS/ISO 13485 freelancer, consultant or consultancy 💼
Freelance QMS consultants know the ISO 13485 requirements upside down and back to front. They will bring years of expertise to the table, and will be able to give you numerous examples of where they have built successful, lean and ISO 13485 compliant QMS systems for startups in the past. They will get the project done quickly and will be able to work very independently. However, this experience comes at a premium price. Once the project is finished, the experience and knowledge you’ve paid for will not stay in-house, so you need to think about knowledge transfer and who will maintain the QMS long term, over time. Freelance consultants are an excellent solution for time-poor startups needing flexibility, who have big budgets.
Hire an ‘in-house’ ISO 13485 employee 👩💻
Another common approach startups take is to bring someone into the business as an ‘in-house’ hire. This person will likely come from another medical device manufacturer, and will have experience building or improving QMS to ISO 13485 standards. This permanent hire will add to your fixed cost base, but generally will come with a whole host of extra benefits. They should be viewed as an investment for the business, as they grow professionally and customise their work to the businesses’ needs. Startups can also use this opportunity to find a fantastic candidate who will fit the company perfectly in terms of personality and values, with a view to retaining them as the business grows and more devices are launched. Our highly coveted network includes thousands of medical device and IVD professionals, many of whom aren’t currently actively applying for jobs but would love to hear about a fantastic opportunity like this.
Finding the right candidate for ISO 13485 🤝
Whichever path you choose to take – consultancy or a permanent hire – it is important you find the perfect match for your business and product needs. Check out our Talent Insights report to get a better understanding of what MedTech professionals are looking for from their employer. If you still feel unsure about which route to take, our team of recruitment consultants are on hand to talk you through the options available. We have years of experience working with medical device and IVD startups, QMS professionals and helping companies find the right person for ISO 13485 compliance. Get in touch today to see how we can help you find the perfect person for your team.