Vincent F. Cafiso Email & Phone Number

New York, NY, US

Durham, NC, US

As the leader of CREO's quality and regulatory services practice, I engage with clients in the life sciences industry to understand their unmet needs and implement streamlined and practical solutions with a focused and personal approach. See "About" above.

I prepared medical device and IVD companies to be ready for their next FDA inspection and Notified Body audit in the areas of compliance, quality assurance, and quality systems.

Watford, Hertfordshire, GB

Leveraging my expertise in Inspection Readiness, as global head of Regulatory Compliance and Quality Audit, I was responsible for ensuring that all S+N design, manufacturing, and distribution sites complied with applicable global regulatory standards as well as key global policies. This remit included establishment and maintenance of the Corporate and.

Franklin Lakes, New Jersey, US

As global head of Regulatory Compliance and Quality Audit for both C.R. Bard and BD, I ensured that the global Corporate audit and compliance programs provided an accurate ongoing assessment of the organization's compliance profile across all design, manufacturing, and distribution sites, that the programs and activities necessary to ensure inspection.

Warren, NJ, US

As overall site quality leader, I led the full Quality Assurance / Engineering, Quality Control, Field Quality, Regulatory Compliance, and Software Quality Assurance programs in support of In Vitro Diagnostic medical device research, product design, manufacturing and distribution. I had full QA oversight over all Design Control activities as well as.

Marlton, New Jersey, US

I led the overall Quality Assurance, Document Control, Repair, and Servicing programs in support of Class III Active Implantable Medical Device (AIMD) design and manufacturing. I had full QA oversight over all Design Control and Clinical activities as well as managing all internal, supplier and third party audits and compliance activities for the company..

Gothenburg, SE

Formerly Datascope Corp., I led the overall Quality Assurance and Compliance programs in support of Class III wound closure and vascular graft medical device design and manufacturing. I had full QA oversight over all Design Control activities as well as managed all internal, supplier and third party audits, compliance activities and recalls for the company.

Silver Spring, MD, US

Experienced medical device and IVD Investigator - I conducted hundreds of complex inspections of manufacturers both domestic and abroad as a member of the Foreign Inspection Cadre - resulting in Form FDA 483 observations, Warning Letters, Injunctions, and Seizures. I was awarded the Outstanding Achievement Award for inspection excellence, acted as.