Medical Device Consulting

We have extensive and diverse experience in medical devices including FDA Class I, II, and III products as well as CMS reimbursement.  We are well versed in the details of new medical device product roll-outs including 510 (k) submissions and full regulatory compliance.

Consulting services that are specific to and specialized for medical devices include:

Engineering Design and New Product Introduction (NPI)

• Multi-market Intended Use statements
• Product testing and regulatory approvals
• Prototyping and testing
• 510 (k) new product registration

Quality Assurance

• Customer complaint management
• Corrective and preventive action (CAPA) procedures
• Non-conformance reporting and resolution
• Qualification of key suppliers
• Inspection planning and record keeping
• Calibration management

Regulatory Compliance

• ISO 13485 process design and documentation
• FDA cGMP and 21 CFR process design and documentation
• ERP and IT system verification and validation
• Compliance pre-audits and certification readiness support

Manufacturing

• Process verification and validation
• Lot and serial traceability

Quality Management System Development

• ISO 13485-compliant documentation
• Document control

Many of the challenges that medical device manufacturers face are well known to us.  Altemir Consulting is familiar with operating within ISO 13485 and FDA cGMP frameworks while managing complex bills of materials (BOMs), engineering changes, and production requirements in the context of a highly loaded manufacturing environment.

Look to Altemir Consulting to help achieve your goals anywhere within the manufacturing supply chain or product development lifecycle.