Establishing the biological safety of a medical device or pharmaceutical packaging system is primarily geared towards providing safe and efficacious products to vulnerable populations. However, these assessments must be designed to satisfy the needs of multiple stakeholders. Amongst those are the regulators, who require thorough audit trails demonstrating a company’s due diligence during the pre-clinical testing phase of product development. Therefore, it is important to embark on the process of developing new products for medical markets with the relevant regulatory requirements in-mind.
At Jordi Labs, we have extensive experience working within the ISO 10993 regulatory framework for medical device biological evaluations, alongside a proven pedigree assisting with pre- and post-market submissions for the US Food and Drug Administration (FDA), as well as European notified bodies. Our team has helped numerous manufacturers demonstrate regulatory compliance by assisting with pre-submission and key submission strategies, for 510(k) and PMA submissions, MDR device registrations, and (A)NDA drug registrations.
Our long history of regulatory consulting has allowed us to foster open lines of communication with regulatory agencies. This allows us to assist in building biological testing strategies (both in vivo and in vitro) designed to satisfy the distinct principles of the most relevant regulatory criteria. We are also primed to provide submission support and assistance for deficiency responses.
Looking for Support with Biological Evaluations?
At Jordi Labs, we can provide end-to-end support with biological evaluations of medical products, assisting at the pre-clinical stage through to market submissions. If you would like to learn more about our regulatory consulting services, why not contact a member of the team today?
If you are looking for support at the outset, refer to our product development strategy page for more information on our approach to certification.