Industry-Standard Compliance

Product Design and Development

Lathrop, the design arm of Paramit, develops products in compliance with industry standards and has been ISO certified since 1998. The design and engineering processes we follow during development are compliant with either FDA Quality System Regulations or the relevant international standards for your specific product. We can readily adapt our quality system to use your existing systems, or apply our own compliant quality system if yours are still under development.

Compliant design control and product development process.

Manufacturing

Paramit is an FDA-registered and ISO-certified manufacturer of medical devices and instrumentation.We regularly examine and assess systems and records to confirm that our company, products, processes, and documentation are in compliance with 21CFR820 and ISO 13485 standard.

Device History Record with vPoke

Traditionally, a device history record is associated with significant costs in terms of human capital, space, process overhead, and even paper. Seeing an opportunity for innovation, Paramit created a patented, computer-directed assembly technology called vPoke. vPoke not only virtually eliminates manufacturing defects from the assembly process but also automatically creates a device history record in real time as each sequence is completed.

If in the future a device fails in the field and you want to review the manufacturing process history for that device, we simply enter the product’s serial number to access and automatically generate the entire device history record, including video images for each sequence. Going well beyond the industry standard for compliance documentation, vPoke lets us handle any inquiry for our clients.

Registrations and Certifications

Design

  • FDA QSR
  • Design History File
  • Device Master Record
  • Human Factors Analysis
  • ISO 9001 Certified
  • Take product to CE mark
  • IEC 60601 and 61010
  • Documented Design Standards
  • ISO 13485

Manufacturing

  • ISO 9001:2008 – UL DQS Registration Number 10002924 QM08
  • ISO 13485:2003 – UL DQS Registration of Quality Systems for Medical Devices. Registration Number 10002924 MP23
  • FDA/GMP – FDA Registered Number 3003537036
  • State of California – Medical Device Manufacturing License Number 50087
  • IPC Certification – Lead Free Electronics Assembly Process Capable