MD-Clinicals

With over 30 years of experience in managing medical device clinical investigations around the globe, MD Clinicals has what it takes to move your product to market swiftly and cost-effectively, saving you precious time and money in the process.

Our unsurpassed clinical and regulatory expertise in medical device market access combined with rigorous anticipatory approach and strong communication means you avoid the unnecessary delays and unexpected problems that affect eight out of ten clinical trials in the world today.

Clinical evaluations and investigations from A to Z:

• Global clinical strategy development including reimbursement • Clinical evaluation report writing

• Protocol design and development

• Investigator brochure writing

• Instructions for use

• Case report form development

• Compliant informed consent

• Site selection

• Investigator meetings

• Clinical trial agreements

• Regulatory and Ethics Committee submissions • Clinical project management

• Product training

• Site monitoring

• Site management (CRC)

• Medical monitoring – Safety reporting

• Clinical report writing

• Data management and statistics

• Clinical auditing

Our team of regulatory and quality experts adopt the most cost-effective approach in compliance with local regulations to get your medical device registered rapidly and efficiently. We also offer a range of industry-lead- ing services designed to optimize the positioning of your product.

• Regulatory strategy development • Medical device registration

• Quality management systems

• Local representation

With over 30 years of experience in managing medical device clinical investigations around the globe, MD Clinicals has what it takes to move your product to market swiftly and cost-effectively, saving you precious time and money in the process.

Our unsurpassed clinical and regulatory expertise in medical device market access combined with rigorous anticipatory approach and strong communication means you avoid the unnecessary delays and unexpected problems that affect eight out of ten clinical trials in the world today.

Clinical evaluations and investigations from A to Z:

• Global clinical strategy development including reimbursement • Clinical evaluation report writing

• Protocol design and development

• Investigator brochure writing

• Instructions for use

• Case report form development

• Compliant informed consent

• Site selection

• Investigator meetings

• Clinical trial agreements

• Regulatory and Ethics Committee submissions • Clinical project management

• Product training

• Site monitoring

• Site management (CRC)

• Medical monitoring – Safety reporting

• Clinical report writing

• Data management and statistics

• Clinical auditing

Our team of regulatory and quality experts adopt the most cost-effective approach in compliance with local regulations to get your medical device registered rapidly and efficiently. We also offer a range of industry-lead- ing services designed to optimize the positioning of your product.

• Regulatory strategy development • Medical device registration

• Quality management systems

• Local representation

Events