Medical consultant

As medical device become heavily regulated and fallowing all the requirement becomes time consuming, you may need the help of a consultant or a freelancer to speed up the processes and ensure regulatory compliance. There’s more than one valid reason to hire a consulting firm. An expert can help you optimise the processes, ensure compliance with necessary requirements and guide you through long and complex route to market while you and your staff focuses on providing income for the company.

In current era of globalization, informatization and increasing remote work culture, highly qualified and skilled experts are making themselves available for consulting projects to businesses of all sizes. This is great opportunity for range of small to medium sized business, who may require specific help and on-demand support with short-term projects. Some of the services medical device consultants can offer include:

 

  • Consultation regarding best regulatory strategy for specific medical device
  • Consultation regarding best regulatory strategy for specific medical device
  • Preparation of documentation for regulatory approval, inspection or certification
  • Performing comprehensive and time-consuming literature searches for clinical and other information about the product
  • Communicating to authorities and ensuring implementation of required actions
  • Providing support and information regarding the best approach for quality and regulatory challenges
  • Specific on-demand support in preparation for documentation submission and / or audits / inspections

Companies now have easy access to medical device consultants for hire, which enables them to ensure their product is safe, backed by reliable data, and in line with country-specific guidelines.

Our experts are educated professionals with extensive experience in the field of medical devices, pharmaceuticals and connected fields. We support companies that are dealing with medical devices at every stage of the product lifecycle. Our experts can work with you, build and maintain an effective quality management system (QMS), manage regulatory affairs and ensure success in bringing your product to market. By outsourcing quality management and compliance handling to experts, medical device companies are able to achieve a quality-driven culture and focus on what they do best – providing service to customers and placing products on the market.

Medical consultant

Define why do you need a medical device consultant:Define why do you need a medical device consultant:The basic question that you need to ask yourself is “What needs to be done?”. By defining the scope of the project, you be able to get the most out of the activities performed by the consultant and separate the outsourced activities for you daily operations. Example of the activities and typical services that medical device consultant offers include:

 

  • Improving and optimization of ongoing processes
  • Analysing clinical information, preforming literature search and preparation of clinical evaluation review
  • Researching the best regulatory approved action plan to guide the product to the market
  • Preparation of documentation for submissions (including preparation of technical file for medical device)
  • Communication with authorities and handling of issues and / or non-compliances

Medisint can offer you services of experts with specific area of expertise matching you project goals. By employing consultants that are highly familiar with your industry and a specific product category and required service. Medisint team will be more likely to improve the quality of the project and take less amount of time to achieve those results. As an independent consultant company, Medisint has established a professional network of partners that assist you in other fields and prove to be another asset you could benefit from.

Our main goal at Medisint it to provide you with valid and reliable information. In this way we can help you make better, more informed decisions. If you have any question or would like to use any of our services feel free to contact us.