Pilot Phases and Clinical Trials
Medical Product Development Support
Historically, developers of medical products have viewed the pilot phases and clinical trials of a project as obstacles to “get past.” In practice, however, the pilot phases of the project present opportunities for enhancing speed-to-market, as well as cost efficiencies. After all, how the end product will be manufactured, packaged, and assembled must be considered long before the first final product unit ever goes into production. The same holds true for how final manufacturing will be automated to keep the cost per unit to a minimum. In fact, not considering design for manufacturing and automation early in the process can lead to complications and delays that can doom the project.
Phillips-Medisize understands that speed and efficiency during your program’s pilot phases and clinical trials are critical to your success. When you partner with us, you benefit from our expertise bringing new medical technologies to market, every step of the way. You also receive guidance through product development, past clinical evaluations, to market launch, and into high-volume production with as few complications as possible.
On your behalf, we’re also committed to the quality systems management of your program from concept to commercialization, and during pilot phases and clinical trials. For your program, Phillips-Medisize helps you comply with drug and device regulations, as well as current Good Manufacturing Processes (cGMP) and Quality Systems (QS).
White Paper: How to Maximize Speed and Efficiency of Medical Product Development During Pilot Phases and Clinical Trials
During pilot phases and clinical trials, Murphy’s Law applies: If anything can go wrong, it will. Discover the key to avoiding the consequences of unanticipated problems.
Quality Certifications and Compliance
- Prior successful implementation and maintenance of applicable Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMPs), for 21CFR parts 210/211 drug packaging requirements and FDA 21 CFR Part 820 Quality System Regulations
- ISO 9001, 14001, and 13485
- Ability to provide a full range of Phase I through Phase IV product development capabilities, including design verification and clinical builds
- MHRA Product Certification (European)
- MHLW Device compliant (Japanese)
- CE Marking (93/42/EEC)
- RoHS-compliant manufacturing process
- UL CSA TUV certifications
- Certified Class 7 and 8 clean rooms
- Support of class I, II, and III devices