Consultation
What Does a Medical Device Consultant Do?
A medical device consultant provides research, product development, regulatory services, and recommendations on a variety of other relevant areas.
A medical device consultant can guide you through several areas within medical device development and regulatory compliance.
Consultants can help you implement a medical device QMS software solution, choose the best pathway for regulatory compliance, improve the quality of your core processes, and create long-lasting value.
Typically, consultants have expertise in areas such as:
Overall business strategy
Quality Management System
Regulatory Submissions
Medical Device Classification
Design & Development
Clinical QMS
Regulatory Affairs
Tips on Selecting the Right Consultant
Choosing the right consultant depends on several factors – project goals, company size, geographic location, budget, and more.
Ultimately, you want to pick the consultant that matches your needs the best. Here are some questions to ask yourself and things to keep in mind when selecting the right medical device consultant.
1. Decide if You Want To Work With a Consultancy or an Individual Consultant
If you decide to work with an individual consultant then you will need to do the due diligence of finding, evaluating, and choosing the right expert.
On the other hand, if you choose a consulting company, then the firm will likely assign one or more relevant consultants for you.
2. Identify Why You Need a Medical Device Consultant
Whether you hire an independent consultant or a medical device consultancy firm, you will want to be as specific as possible to match the competencies of the consultant to your needs. To find the right expert, define the project requirements, and ask yourself, “What needs to be done?”
3. Does the Consultant’s Area of Expertise Match Your Project Goal?
The level of expertise for consultants can vary greatly, and typically the value that can be provided by the consultant drops once they get out of their area of expertise. Thus, you want to make sure that the consultant’s area of expertise matches the requirements of your project.
4. Has the Consultant Worked With Your eQMS?
Whether or not the consultant has experience working with your current eQMS software should not be the most important factor when making the final decision.
Although, training your consultant on how to use your eQMS solution would only require you to invest more resources, making the real costs for the consultant even higher.
If the consultants have prior experience with your QMS software solution, they could also help you implement the best practices so that you could reap all the benefits of your eQMS.
5. Does the Consultant Have Experience With Similar Clients?
Smaller companies operate differently than larger companies. By nature, small companies, including medical device startups must be agile, which pushes them towards greater risks due to limited funding.
On the other hand, established companies have mature and advanced systems, which startups cannot implement so easily.
Consultants who worked in large medical device companies before providing independent consulting services may find it challenging to work with smaller companies.
At the same time, consultants who only have experience with smaller medical device companies might struggle with project deliverables for a large firm.
Therefore, make sure that the consultant has experience with companies of your size, so you can achieve the desired project outcome while using resources wisely.
6. Does the Consultant Work in a Favorable Geographical Location?
It is also important to consider the geographic location of the consultant. Especially if your project involves a consultant working at your location.
The consultant’s primary location might also be relevant when it comes to understanding local market conditions and requirements.
However, if your projects allow for remote work, then you should consider taking advantage of a wider talent selection. If you choose to work with a consultant remotely, project management might prove more challenging.