Tartarini Consulting, LLC

WHAT WE DO: We help Medical Device Manufacturers and Suppliers achieve and maintain regulatory compliance by providing quality consulting services.

WHY IT WORKS: When you partner with Tartarini Consulting and Associates you get the most efficient, effective, affordable and professional consulting services that Medical Device Manufacturers and Suppliers are looking for. Our knowledge and experience help you avoid costly mistakes while ensuring the systems needed to ensure compliance operate effectively and efficiently by using proven methods and practices.

WHAT MAKES US DIFFERENT: Regulations and standards identify “What” must be complied with, however, they don’t identify how to comply. We help our client navigate the maze of regulations/standards by ensuring procedures and practices add value while providing compliance. While working with clients we don’t just identify gaps or nonconformance’s; we educate and help prepare for notified body audits and regulatory inspections.

HOW IT WORKS: We start by understanding your needs and objectives. Next, we tailor a plan that fits these objectives; including time frame and costs. Assurance of compliance can be achieved by:
• Conducting a Gap assessment to identify gaps in the existing quality system,
• Conducting an audit to identify whether the implementation of the quality systems, procedures and practices comply with internal company policies/procedures and industry regulations/standards,
• Correcting audit nonconformance’s or regulatory inspection observations using structured problem solving and effectiveness verification to ensure issue resolution and on-going compliance.

AREAS OF EXPERTISE: Quality Auditing | Regulatory Compliance | Medical Device Regulations | Design Controls | Production & Process Controls | Complaint Handling | Risk Management | Supplier Controls | Training Delivery | Project Management | Corrective and Preventive Action (CAPA) |Quality System Compliance Remediation

Company’s Keywords:

software development, quality auditing, corrective & preventive action, regulatory compliance, quality management systems, quality system training, gap assessments, quality system remediation