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 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’ 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 🤝
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.
5 signs of a great regulatory affairs recruitment agency
Finding regulatory affairs talent – especially at a senior or leadership level – can be a challenge. Whether it’s for a newly created position or to fill a recent resignation, finding and then securing the perfect candidate can be difficult. There are so many elements that come into play: finding someone with the required (or better!) experience, attracting exceptional candidates that maybe aren’t yet actively looking for a job, ensuring that the person you hire has the right attitude and personality to fit in with your company, creating the perfect job offer that your chosen candidate can’t say no to.
Now factor in another layer of complexity – finding regulatory affairs talent in the medical devices and IVDs industry. Finding the ideal candidate in this niche industry can sometimes feel like looking for a needle in a haystack, especially when you are trying to meet all the criteria listed above. It’s possible that the right candidate for you – the one with the perfect experience, attitude and expectations – is only just starting to think about a new job, in which case they won’t be actively searching for roles or looking at medical device regulatory job listings. How can you possibly let them know about your fantastic job offer in regulatory affairs if they aren’t looking on your website? Capturing the attention of that person, whilst looking through the haystack at the same time…. It isn’t easy!
At this point, where the fear creeps in that you might never find the perfect person to join your company and help push it forward to greater success, it’s time to enlist the help of a recruitment agency. Not any recruitment agency either – you need a great regulatory affairs recruitment agency that specialises in medical devices and regulatory affairs. Look out for our 5 markers of a great regulatory affairs recruitment agency to know you’re working with the right one!
1. Specialists in medical devices and regulatory affairs
Most generalist agencies will recruit across multiple industries and lots of different role types. They might have a good approach to recruitment and attractive rates, but do they have the network, proven track record and trust of the candidates you are trying to reach? Great agencies will be medical devices and regulatory affairs experts, with a laser-beam focus on what it means to be a successful medical devices company in the current market. They will talk confidently to you about the impact of changing regulations such as MDR and IVDR, and the implications such changes might have on your business’ hiring needs later on down the line. How can you know what you’re looking for is realistic, that you’re paying the right salary, and what it is that makes you stand out against all the other roles in regulatory affairs? They will share their own market insights and data with you, to make sure you have all the relevant information needed to make the right hiring decisions for your business.
2. Connected to a wide network that you would otherwise not have access to
A fantastic regulatory affairs recruitment agency will have a warm database of candidates who engage with them on social media, on their website, by email, and as part of company events and programs. They will have relationships that mean that when they call, your perfect candidate will answer. This network of regulatory affairs professionals – all with the kind of medical devices experience you are looking for – might not be actively looking for new jobs. But with the visibility that a great regulatory affairs recruitment agency can provide in terms of promoting new jobs and the insights they have over signals that suggest someone might be about to look for a new job – this means that suddenly, with the right agency, your open positions are being presented to exceptional candidates who would otherwise not have seen them.
3. Embedded in the medical devices community
It takes a really great regulatory affairs agency to not just work in the medical devices industry, but to be valued as an important and contributing part of it. This makes the conversations between recruitment consultants and candidates even smoother and more effective, as they already know and respect the business and its team. Look for agencies who are thought leaders – those that are considered integral to the industry by its members, with team members who lead the way in terms of medical device conversations and resources. These agencies are more than just suppliers, they are trusted strategic advisors.
4. Proven success rate with companies like yours
A great regulatory affairs recruitment agency will have a fantastic history of success – look for how many years they’ve been operating for (especially in medical devices and regulatory affairs) and great client testimonials that speak to the hiring challenges you are facing. It’s important to not just focus on the client side; look for candidate testimonials and don’t forget that your chosen recruitment partner will be an extension of your company brand. They will represent you in the market. Testimonials are excellent proof that the agency you’re considering puts time and energy into creating perfect client/candidate matches. One challenge you may be facing when recruiting senior regulatory affairs professionals for medical devices is simply having the time to find the best candidate. Great agencies with well-versed processes and proven success rates run efficiently and effectively, meaning that you can put your trust in them to do a brilliant job.
5. Supportive throughout your entire working relationship, not just when you have a position to fill
A really great regulatory affairs recruitment agency will be there for more than just finding and placing your candidate. They will be there to support you at the very start of the process, when you’re facing an unexpected resignation or are trying to benchmark salaries. They will use their specialist knowledge to help you understand the talent landscape, employment trends, and give you competitive market insights that you won’t be able to find publicly.
Use this list as your checklist when assessing regulatory affairs recruitment agencies for your medical devices hiring needs. Do research on social media – especially on LinkedIn – and visit their websites to get a better understanding of their calibres. Speak to industry peers for verbal recommendations and, if you’re curious to know how the team here at Elemed can help, get in touch with us now.
What is post market surveillance for medical devices?
Your new, cutting-edge medical device has been designed and tested, and is ready to get out into the world to start making a difference to patients around the world. You have a stellar go-to-market strategy in place and can’t wait to show your customers just what your new medical device can do. But how do you make sure your medical device stays safe and effective once it’s on the market? Post market surveillance is the answer. This system – which is a regulatory requirement for medical devices in Europe and the US – enables continuous feedback about your new product in the market, with a view to maintaining a high standard of product quality.
It’s important to get your post market surveillance system working well. The benefits include being able to improve your medical device and deliver better results for your customers, and catching any problems before they happen at scale. Implementing a post market surveillance plan isn’t as simple as it sounds though. As a regulatory requirement, post market surveillance comes with a whole host of obligations and responsibilities that can make it feel overwhelming.
Hiring a talented professional who specialises in post market surveillance for medical devices is the best way to ensure that your system is enabled effectively, efficiently and with full compliance. Read on for the 3 sure signs that your post market surveillance candidate is great at what they do!
Core competencies 💪
There are certain core competencies that every excellent post market surveillance professional should have. Your checklist should include direct experience leading post market/complaint handling and vigilance activities. If they have a Bachelor’s degree in engineering or science degree that’s a bonus! Perfect candidates will have 3-5 years of related experience in the medical device industry too. You’ll also need to look for someone who has demonstrable experience in regulatory audits, incident reporting and working to medical device regulations including MDR and ISO13485.
Standout skills 🧠
It’s not all about the person’s hands-on post market surveillance experience. A great PMS professional will have soft skills that really shine. You need someone who can confidently make decisions and effectively communicate detailed, technical information and strategic decisions to colleagues at every level across the business. Post market surveillance is all about processes, so your dream candidate should excel in implementing, optimising and driving processes across organisations. They will have a keen eye for trend analysis, with a commitment to accountability and a strong customer focus. You should also look out for candidates who show the ability to think quickly, react confidently and work efficiently in the face of a problem or complaint.
Unrivalled passion – even for regulations ❤️
Look for someone who doesn’t just know their MDR from their IVDR, but who lives and breathes them. A great post market surveillance candidate will be passionate about every last detail of their work, down to the smallest regulatory requirement. They will thrive in the face of compliance and love the challenge of watching a great medical device work its wonders for customers whilst looking for ways to improve and optimise its performance.
What happens when you find your perfect post market surveillance candidate? 🤝
So you’ve found your ideal post market surveillance professional – what now? The worst possible outcome is that they decline your offer or take a job elsewhere. Excellent candidates are worth fighting for, so be prepared to pay close attention to their expectations and motivations. Do they want a few days working from home each week? Are they financially motivated and expect an annual bonus on top of base pay? Maybe taking care of their mental health is a top priority for them and they’re looking for a role with genuine support. Whatever it is that your candidate is looking for in their dream job, if they are your dream candidate it is worth being flexible and meeting their expectations where you can. Don’t just take our word for it – we have data in our Talent Insights Report that shows how work-life balance is extremely important to candidates – 91% of participants expect their company to offer flexible working hours and 73% expect the possibility of working from home.
Where to start?
If you’re ready to find your perfect post market surveillance professional but aren’t sure where to start, we can help! We have a network of over 15,000 medical device and IVD professionals, and have lots of experience filling exclusive roles. Our network includes some of the best post market surveillance medical device talent in Europe, with many of our professionals waiting on their perfect next career step. These aren’t people sending out their CVs every day in the hope that they find the right position – they are relying on our help to bring the dream position to them. If you want to find out more about how we can help connect you to your perfect post market surveillance candidate, get in touch today!