Joseph C. Griffin

Lead overall regulatory affairs and quality assurance for Company's products and services. Obtain domestic and international regulatory product approvals. Grow and maintain Company quality system and ISO compliance. Official regulatory and quality representative. Conduct Clinical Trials.

Medical Device Industry Consultants • Regulatory Affairs, FDA and EU MDD • FDA IDE, PMA, 510(k), CE Marking Design Dossiers • Quality Systems, ISO and QSR • Design Controls • Manufacturing • Product Development • Machine Design • In-house Machine Shop • Mfg. Jig and Fixture Fabrication • C

• Obtained ISO 9001 and EN46001 Quality System Certification for the Company and product CE Marking for all of its class II and class III devices including the compilation of design dossiers. • Prepared and filed a Modular PMA Class III device submission with the FDA for the Company’s ALERT® cathet

Operated 30 Unit, 100,000 sq. ft. light manufacturing and office Condominimum complex. Conducted all board meetings, reviewed and approved all expenditures. Directed retained tax account and legal counsel. Responsible for maintenance of Master Deed common elements and fee assessments.

Founder of this cardiovascular catheter manufacturing Company. Sold business to EP MedSystems, Inc. in November 1993 where the business was renamed ProCath Corporation. I remained with the Company until retirement from EP MedSystems, Inc. in June 2000.

• Transferred new pacing lead manufacturing technology from Dr. Osypka, GmbH., Germany. • Sourced and qualified new US based vendors for critical pacing lead components eliminating import costs from Germany. • Converted 12,000 sq. ft. of non-functional facility space into class 10,000 assembly cle

• Designed, developed and patented a disposable pressure transducer tipped catheter which eliminated the need for external pressure transducers that are subject to numerous errors. • Developed and patented the first dual-thermistor thermodilution catheter in the industry. Design eliminated the need

• Team member in the integration of catheter technologies during acquisition of American Catheter Corporation initially by Extracorporeal division of J&J and subsequent internal J&J acquisitions by Handcock Labs, Vascor and finally Critikon. • Designed and drafted from conception to production card

• Created isometric conceptual product drawings. Produced electrical schematics, hydraulic schematics, cooling water schematics and mechanical assembly drawings for mega sized induction melting furnaces for the largest foundry companies worldwide. Traveled with the Company pilot / head engineer, in