Our broad range of consulting services are designed to help small and medium sized companies maintain compliance with the ever-increasing quantity and burden of regulatory requirements while maintaining cost control and improving effectiveness.
Product Approvals and Licensing
In addition to preparing Section 510(k) Premarket Notifications, The CRO Group consultants specialize in preparing European technical files and design dossiers and Canadian license applications, and the supporting documents which are generally required including Risk Management Files, Software Documentation, etc. We also have prepared 513(g)s, DeNovo submissions, IDE's, and PMA's.
Quality Systems
Whether you are starting up a new company, preparing for ISO 9001 or 13485 certification, certification to the European Medical Device or IVD Directive, or FDA inspection, or attempting to bring a costly, overcompliant certified quality system in line with budget, The CRO Group consultants have worked for
both leading Registrars/Notified Bodies
and medical device manufacturers, and are uniquely qualified to provide a solution tailored to your company, easy to implement, and not requiring excessive overhead to maintain.
Part 11: Electronic Signature/Records
The FDA with little advance warning, rescinded the many guidances and declared that several of the "difficult" requirements of Part 11, including the generation of unalterable audit trails was being placed on a discretionary exemption under certain circumstances. Since then, our understanding of Part 11 continues to evolve. Whether you are going "paperless" with an EDMS, ERP, or are thinking you're avoiding the regulation by maintaining paper records with your electronic system, The CRO Group can assess your electronic systems, perform gap analysis against the existing regulation as well as our understanding of what is expected to change, and perform system specific or overall remediation services to get your electronic systems into compliance.
Risk Management
Starting in 1993 in the EU Medical Device Directive, in 1996 in the FDA QSR, and then in 2003 in ISO 13485, the message to medical device manufacturers as well as other regulated industries is clear - Risk Management shall be applied throughout product realisation. From applying the ISO 14971 standard, to setting up Risk Management in Purchasing, Production, Warehouse, and countless other operational areas and processes, The CRO Group can assist you.
Clinical Audit
We support our clients with audits and tailored standard operating procedures for the sponsor, investigator, and the CRAs. Medical device companies wishing to run a collateral European or Canadian trial often turn to CRO Group for standard operating procedures which ensure compliance with all regulations, standards, and guidance.
Human Cells and Tissue Products
We support our clients with audits and tailored standard operating procedures for the sponsor, investigator, and the CRAs. Medical device companies wishing to run a collateral European or Canadian trial often turn to CRO Group for standard operating procedures which ensure compliance with all regulations, standards, and guidance.
