It may be difficult for a medical device company to choose the right partner and achieve its marketing goals, especially if part of the information is missing.

That is why this choice is crucial to ensure that all regulatory requirements are met, research and development activities proceed smoothly and the time-to-market is as short as possible.

There are several solutions when choosing the most suitable suppliers as there are numerous freelance consultants, structured companies or referral entities available on the market.

However, you have to consider different elements including those related to the organization, such as its goals, target countries, size and budget.

This article gives you the right elements to make a proper assessment when choosing the most suitable partner by answering 3 key questions that you should always ask yourself.

  1. Freelance consultant or company?

Choosing a freelance consultant might be more convenient in terms of costs and investment perspective. They are professionals with no significant organizational costs, resources or infrastructures and might offer a competitive hourly rate.

However, considering the current regulatory scenario (very complex, always-evolving and projected towards the internationalization), you should bear in mind that a freelance consultant may not have all the expertise and necessary skills to exhaustively satisfy the client’s needs.

Moreover, while a company may rely on its own staff, differentiated by skills and areas of expertise, it may be willing to accept much larger workloads than a freelance consultant who may have limited time.

With regards to representative regulatory services or in case of outsourcing, the chosen partner must also be qualified as a critical supplier. The chance of finding a company that can meet this qualification through certification process or an enforced and inspectable quality management system is certainly higher in the case of a company.

  1. What kind of support should the ideal partner offer?

The ideal partner should not only carry out operational activities but also offer support at a strategic-regulatory level in order to contribute effectively both to the full development of regulatory and Quality activities and to research, product development, design, and product commercialization.

The ideal supplier’s skills should be as follows:

  • Business strategy
  • Knowledge of the medical market
  • Quality Management System
  • Regulatory Submissions
  • Medical Device Classification
  • Design & Development
  • Regulatory Affairs
  1. What role should you give to the ideal partner?

In order to make the right choice, it is important to understand what role you want to give to your future partner. The partner’s task could be just to provide the right information so that action can be taken, or they could be called upon to give real operational support, acting as an outsourced provider.

In both cases however, it is important to remember that it is not recommended to totally rely on the partner by completely replacing the company with him in and therefor making him responsible for all the company’s activities. As a matter of fact, the company should always have full control of its procedures and activities and only use the supplier as an operational support.


Companies operating in the medical field may need to bridge or integrate their experience and expertise in Quality/Regulatory Affairs as well as product development and commercialization. In this case, it may be useful to choose the support of a specialized partner, consultant or company, based on the organization’s own characteristics and target objectives.

This choice can be driven by answering several key questions aimed at identifying the most suitable partner (company or consultant, with what skills), the type of support needed, and the role to be assigned to the selected partner. The latter should not totally replace the organization that must maintain procedural governance.

The right partner for you

Thema offers strategic-regulatory consulting and training services to companies operating in the medical industry.

A structured organization, the contribution of top-notch professionals and a certified process quality system make Thema the right partner for you. With great flexibility and expertise we can integrate your knowledge to make the best decisions and thus achieve your business goals in the right timeframe.

Contact us for more info.