We are usually asked about:

How should I select a clinical and regulatory affairs outsourcing company?

When selecting an outsourcing company in Clinical and Regulatory Affairs field, MedicSense suggests that you verify that candidates can offer the following:

  • A proven track record in the medical industry field.
  • A company that understand your technology and procedures involved.
  • A company that provides quick response time, maintains high standards of customer service and has a customer oriented attitude.
  • A company that provides cost-effective solutions.
  • A flexible organization that can accommodate your specific needs
  • A company that assigns a one-on-one liaison who provides ongoing support to your project.
  • References from satisfied clients.

What is the working process with MedicSense?

One of our senior staff members will meet with you to assess the specific requirements of your project and how we can best customize our services and knowledge to accommodate your specific needs. We then provide you with a detailed step-by-step proposal describing the work to be performed. In addition, we offer flexible financing options; we can work on a retainer basis, on individual assignments or a combination of both. Once a working plan has been determined upon, we will price the work and define the time table.

How does MedicSense safeguard all client confidentiality and proprietary information?

Your need to protect your valuable proprietary information is of the utmost concern to us at all times. Accordingly, we enter into non-disclosure agreements with each and every client with whom we do business. In addition, all our employees are obligate by contract to keep your intellectual property strictly confidential.

What types of companies can benefit from the services offered by MedicSense?

All companies – large and small – working in the medical device field can benefit from our services. Even companies that opt to employ a full-time specialist stand to benefit greatly by availing themselves of the additional support services that our many years of experience enable us to provide.

Can MedicSense offer "US Agent" - based representation?

The United States FDA requires that non-American companies wishing to market medical devices in the US appoint a US-based agent. In contrast to non-US based regulatory companies that appoint an American company (3rd party), MedicSense, through our MedicSense USA, our American subsidiary, provides you with direct regulatory professional US agent representation.

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