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Contact:  Tom Colonna, Principal
Specialty: Medical Devices

Pinnacle MedTech offers clients a full range of services to support their regulatory, quality and product development needs. The Pinnacle MedTech team of senior level professionals has extensive experience working with start-up to large scale medical device organizations.

• Concept Ideation and Design Feasibility
• New product development and engineering support
• ISO registration/CE marking
• Technical Files/Design Dossier
• FDA Submissions and support
• International Product Registrations
• Clinical Evaluations
• Audits (Internal/Supplier/Regulatory Audit Preparation)
• Quality System Development
• Remediation (Warning Letters/Recalls/CAPA)
• Adverse Events Reporting
• Labeling Requirements and UDI
• Manufacturing management and contract services

Years in business: 1


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