Medical Device Consulting

Whether you need help with submissions, responding to Regulatory Authorities regarding regulatory compliance, or help with a multi-country strategy, PAREXEL Consulting has the exact expertise you need for medical device development and commercialization success.

Medical Device Consulting Tailored to Your Exact Needs

At PAREXEL Consulting, we tailor our Medical Device Consulting to your product and indication by selecting the right experts with an in-depth understanding of the challenges and opportunities your product creates. These experts are on top of the latest medical device regulatory requirements and guidances and can offer broad insight into medical device reimbursement and market access, strategic compliance and safety. Our experts include FDA Consultants and EMEA Consultants who were former senior regulators in those agencies, PhD/MD scientific, technical and therapeutic experts, and seasoned medical device industry specialists.

From development stage through global companies, we can help you understand the regulatory landscape for your medical device and provide a fully integrated approach to device development including design controls, and effective communications with Regulatory Authorities related to product development and post-marketing activities.

Key Offerings

• Market Assessment
• Product Development & Commercialization Strategy (Device and Device / Diagnostic Combination Products)
• Reimbursement and Market Access
• Regulatory Classifications, Applications and Submissions
• 510(k), PMA, IDE, CE-marking
• Regulatory Liaison and Response
• Notified Body Choice and Liaison
• Innovative Clinical Trial Design and Management
• Language & Labeling
• Medical Communications
• Strategy Compliance and Risk Management
• Quality Systems (QSR, ISO 13485, ISO 14155)
• Independent Third-Party Audits
• Due Diligence Audits
• Validation Solutions
• Inspection Readiness Preparedness and Training
• Crisis Management
• Post-Marketing Regulatory Services

How we do it

• Analyze the benefits / risks for informed decision-making
• Interpret the regulatory precedents and new legislation
• Understand the competitive landscape
• Develop the business and regulatory approach
• Conduct persuasive communication with authorities
• Execute an effective path to approval
• Effectively coordinate development in multiple markets
• Select appropriate testing and manufacturing vendors
• Establish a compliant Design Control System
• Ensure overall compliance with QSR and EU regulations
• Properly employ international standard

Your Advantage

• Access to a global network of top level consultants
• In-depth global marketplace knowledge and experience
• Expertise fusing science / technology, regulatory and business
• Complete product lifecycle suite of integrated services
• Broad insight into your development program

Contact Us

For further information and to get in touch with our Medical Device Consulting experts, please use our Contact Us form and type "Medical Device Consulting" in the comment field or contact Barry Sall, RAC,Principal Consultant. Thank you!