Haven Mccall Email & Phone Number

Salt Lake City, Ut, Us

Novo Laboratories is an innovator in the field of regenerative medicine. Since our inception in March 2020, we have been at the forefront of biologics, committed to exploring the vast potential of human cells and tissue products. Our foundation lies in the collective expertise of a diverse team of scientists, researchers, clinicians, and industry specialists, all united with a singular vision: to revolutionize the landscape of healthcare through regenerative therapies.

Baltimore, Md, Us

Teach graduate level courses with a focus on global medical device regulations for biotech products.

Salt Lake City, Utah, Us

BioUtah is an independent, non-profit trade association serving the life sciences community in the state of Utah. We are comprised of manufacturers and developers of medical devices, pharmaceuticals, diagnostics and biotechnology products as well as government, academic and health care institutions all focused on improving health and wellness through the delivery of innovative technologies and services. We are passionately focused on advancing and growing Utah’s life sciences industry and encourage collaboration and innovation amongst our members.

Salt Lake City, Utah, Us

Provide regulatory and quality consulting services for medical devices with a focus on the following areas: US Agent representation, quality management system implementation, auditing, 510k submissions, ISO 13485 certification, CE mark, FDA 483 and Warning Letter remediation, developing global regulatory strategies, FDA establishment registration, FDA communication, quality program implementation, maintenance, auditing, GLP / GMP / processing / manufacturing establishment, product and process validation.

Bluffdale, Utah, Us

Canyon Labs performs laboratory testing, quality, regulatory, scientific & technical consulting for products regulated by the FDA.

South Jordan, Ut, Us

Responsible for ensuring regulatory requirements are effectively established and maintained in harmony with global regulations, standards and directives. Ensure compliance to global quality system regulations, standards, directives and requirements, including USA FDA, GMP, ISO 13485, MDSAP, EU MDD and MDR, Australia TGA, Brazil ANVISA, Canada - CMDCAS, Japan MHLW/PMDA, China, KFDA, etc. Maintains oversight of FDA and Notified Body inspections and audits.

Lead all aspects of regulatory affairs and quality assurance with emphasis on compliance to GMP requirements and ISO standards. Developed and implemented regulatory strategies and processes. Was responsible for 510k submissions, CE mark and international submissions, registrations and renewals for medical devices. Ensured compliance to FDA regulations, EU Medical Device Directive (MDD), Canadian Medical Device Directive and other regulatory agencies. Facilitated FDA, Notified Body and all other regulatory agency inspections and audits.

Chicago, Us

Worked within GE Healthcare's portfolio of healthcare consulting and support services. Was responsible for the execution of services that supported the quality, regulatory and medical strategy. Ensured program outputs were compliant with domestic regulations and international standards.

Newark, Delaware, Us

Product surveillance of Class III medical devices, including cardiothoracic, interventional, endovascular and general surgical products. Led multiple teams with responsibilities for complaint handling, medical device reporting, vigilance reporting, risk management and device tracking.

Doctorate (Drsc), Regulatory Science

Master Of Science (Msc), Regulatory Science

Masters In Business