Medical Device and Diagnostic Expertise
PPD can help you build strong development strategies, whether a medical device is targeted to domestic or global markets. We understand the unique challenges of medical device development: intense competition, precise regulatory requirements and management of the product over its life cycle.
PPD has the global resources and local regulatory knowledge to facilitate effective strategies for approval. Our highly experienced medical device specialists provide innovative, results-focused support for our clients' clinical and regulatory needs.
Comprehensive Development Services
PPD’s cross-functional medical device and diagnostic product development team is comprised of clinicians, clinical operations experts, regulatory experts and biostatisticians. PPD experts have deep experience in development planning and regulatory representation across a wide range of technologies and platforms, including companion diagnostics. PPD offers full-service consultation for medical device and diagnostic development across multiple therapeutic areas, including:
- High-quality strategic consultation for device and combination product development
- Customized regulatory submission preparation
- Pre-submissions for early consultation and interaction with regulatory authorities
- Clinical trial authorization (CTA) and investigational device exemptions (IDE)
- Marketing authorization – 510(k) premarket notification, premarket approval (PMA) application and marketing authorization application (MAA)
- Humanitarian device exemption (HDE)
- Requests for designations (RFD) for combination products
- Evaluation of notified bodies (NB), preparation for NB audits, preparation of technical dossiers
- Interaction/meetings with regulatory agencies at every stage of development
- Import and export consultation for global device development
- Due diligence to assess regulatory compliance
- Post-approval/post-clearance support to maintain the safety, effectiveness and performance of the device throughout its life cycle
- Registration and listings, labeling updates, design changes and enhancements, corrections, MDR reporting and recalls,
- Post-approval studies
- Submission updates to regulatory authorities
- Annual reports and changes requiring pre-approval or notifications
PPD’s medical device and diagnostic development team utilizes our global presence and comprehensive experience to help minimize delays and increase the efficiency of your device or companion diagnostic program development program.