How to get the right people in place for the MDR and IVDR

Author: Luke Webber
Posting date: 04/12/2017

In an already competitive market for talent, the task of assembling a highly skilled workforce to carry out your compliance plan for the new medical device regulations will be no easy feat. Getting the right people in place will undoubtedly affect your existing workforce, but the most important aspect to consider will be the additional personnel you’ll need to set your company’s compliance plan in motion. Here are some steps to follow to get the right people in place for the MDR & IVDR:

Assemble a team to assess the situation

Before you consider onboarding any  additional staff, look to your existing workforce to kick things off. Begin by assembling a multi-disciplinary team to carry out essential tasks such as reviewing the new regulations and assessing how to move forward with the changes.

It’s a good idea to do a gap analysis of various areas within your business. Without doing this first, it’s difficult to gauge which resources you already have and what is needed to move forward. Some areas will need particular attention, for example when reviewing clinical evidence and technical documentation, as the new regulations require a significant increase in both of these areas. You should also test your existing systems to gauge their capabilities, harmonise your standards and do your best to clear any existing corrective and preventative actions (CAPAs). This will help you to work out how to best utilise your existing workforce, and make it easier to work out the extra resources you may need across each business function.

If you think that this will be taking your staff away from other important tasks, consider employing external resources such as a specialist consultancy to help you conduct a thorough gap analysis.

Plan who you will need

Once a thorough review and assessment has been carried out, you can begin to formulate a plan of how your company is going to become compliant with the MDR and/or IVDR within the strict time-frames. As you go along, consider each action point and which resources – existing or new - you need to see it through successfully. One of the most important things to plan for is the time it will take to hire the people you need and the cost of recruiting, onboarding and training them.

If you get stuck here, unsure of which skillsets are needed, the safest course of action is to consult experts within the industry. For example, a specialist life sciences recruitment consultancy, such as Proclinical, can utilise their experience working on similar projects within the medical device industry and advise on the type of resources you need, as well as whether select individuals or entire teams are required. They can also advise on whether you need staff on a permanent or contract basis, or provide you with a tailored, cost-effective solution.

Other benefits of using a life science recruitment consultancy:

  • Access to a large network of talent
  • Ability to engage candidates with in-demand skillsets
  • Experienced in delivering high quality staffing solutions within strict timelines 

Hire your MDR workforce

With a great compliance plan and list of resources in hand, you’ll be in a position to make the hires. This is likely to be a substantial burden on your HR and talent acquisition team, so engaging with a recruitment agency to either head-up your entire staffing strategy or support your team with some of the tougher aspects is also smart move. Remember that failing to put the right people in place can lead to serious consequences for your business. If you hire the wrong people for the job, you risk further delays in getting a license to trade your products in the EU, which could lead to reputational damage and much higher costs in the long run.

Get started early

Starting your preparations early is key to ensuring the availability of staff. These regulations will affect thousands of medical device companies across Europe, leading to intense competition for a finite number of qualified candidates. To have the best chance of becoming complaint within the set deadlines, act early and hire the best of the best. Again, life science recruitment agencies have instant access to large candidate networks and the tools and expertise to install them quickly and efficiently, so it’s worth engaging with one to avoid missing out on the best talent.

Proclinical is a specialist life science recruitment company with extensive experience in providing solutions for medical device companies across Europe. To discuss your staffing needs for the MDR and IVDR, book a consultationwith one of our recruitment specialists at a convenient time for you.