Bio-Engineered and Tissue Engineered Products Expertise
Aptiv Solutions works with bio-engineered and tissue engineered device manufacturers to meet clinical, compliance and FDA CDRH, CBER and international regulatory requirements to bring the product to market, including:
- Bioengineered wound healing products – regulatory strategy and pre-IDE submissions, clinical study design, IDE application, 510(k) premarket notification
- Tissue engineered orthopedic implants – regulatory strategy and pre-IDE submissions, clinical study design, IND
Tissue Engineered Orthopedic Device Case study
A European based tissue-engineering firm needed to develop an FDA regulatory strategy and design an appropriate clinical study to assess the safety and clinical effectiveness of its orthopedic implant consisting of autologous human cells imbedded in an animal-derived extracellular matrix. Aptiv Solutions was able to help the company to develop the appropriate documentation to describe the implant adequately, including the processes for preparation of the animal-derived extracellular matrix, preparation of the human cell population, and the procedures required to manufacture the implant from the human and animal-derived components. Aptiv Solutions also worked with the company to assemble the necessary documentation to effectively demonstrate the safety of the animal-derived matrix proteins and establish performance specifications for the finished device. Aptiv Solutions was also able to assist in developing a clinical study protocol that included the selection and validation of the appropriate evaluation tools to verify integration of the implant into the host tissue, and to develop and validate the appropriate endpoints for assessment of safety and effectiveness.