QUALITY SYSTEMS / CONTROLS / ASSURANCE

Primo Medical Group is an ISO 13485:2016 compliant company. (Download certificates here: ISO 13485 2016). Our quality standards meet or exceed both ANSI/ASQ Z 1.4 and Military Standards and specifications, and we are also a registered manufacturer with the Office of Defense Trade Controls Compliance. Our long-established reputation is built upon our persistence to consistently meet or exceed the quality requirements and expectations of our customers. By maintaining continuous control over all aspects of our processes, we provide our customers with well-documented quality assurance.

Our quality control expertise is in the areas of:

• Customer Specific Quality Inspection Plans
  • Customized Sampling Plans
  • ANSI/ASQ z.1.4 and Military Standards and Specifications
  • Geometric Tolerancing
• Supplier Management
• Statistical Process Controls
• Equipment Installation Qualification and Preventative Maintenance
• Corrective and Preventative Action Program
• Complaint Management
• State of the Art Inspection Equipment
  • Keyence Digital Imaging Systems
  • Programmable CMMs
  • CAD Based Inspection
• Exceptional Level of Training

Other Quality System Services

• Quality Management System Implementation
• Process Validations
  • Capability Analyses
  • Special Validations: Sterilization, Packaging
• Gage R&R Studies
• Component Qualifications
  • First Article Inspection
  • Operational Qualification
  • Performance Qualification
• Test Method Development and Validation
• Software Validation
• Compliance and Remediation Testing
• Gap Analyses
• Risk Management File Development

REGULATORY CONSULTING SERVICES

Primo Medical Group Regulatory Consulting Services provide a full range of regulatory consulting support services to U.S. and international clients in the medical device industry.

Primo Medical can assist with a wide range of services that cover all of the stages in the development process ensuring products meet the requirements of regulatory authorities. Through our close contact with regulatory bodies, we are able to anticipate and advise you on new US and international developments.

Our medical device regulatory consulting services include:

• Regulatory strategies
• Device classification
• Predicate device identification
• Pre-IDE submissions and meetings
• Protocol design
• IDE applications
• 510(k) submissions (traditional and special)
• De Novo submissions
• PMA and PMA supplement submissions
• FDA 483 letter responses
• Warning letter resolution
• Medical device reporting
• Liaise with FDA and European authorized representatives
• CE marking
• ANVISA registration
• ITAR Registration