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Quality & Engineering

Success is built on quality and customer-focused design

Quality Management System – Electronic (eQMS)

Medavise specializes in helping new companies design and implement a QMS tailored to their specific needs while complying with FDA Quality Systems Regulation (QSR; 21 CFR 820) and ISO 13485 requirements. We can help implement a pre-production QMS for companies that are just starting up or establish a fully compliant QMS system for companies that are nearing commercialization. While Medavise can work with any eQMS you might select, we’ve partnered with Greenlight Guru to provide clients with a cloud-based eQMS system that works especially well for start-ups and younger medical device businesses but is designed to keep up with your company growth.

QMS Management

Virtual and younger companies may not have the resources in-house to manage their QMS. We can provide experienced quality engineering and document control support to ensure continued compliance to regulations and successful quality system audits.

QMS Audits

Conducting internal audits is a requirement of both the FDA QSR and ISO 13485. Medavise can assess how well your QMS complies with these regulations through various types of independent audits. Medavise audit services include gap analyses of QMS documentation, full or partial internal QMS audits, and supplier audits.

Design History File

While a clever product idea and design may be the first step, the path to commercialization of a medical product leads through myriad design control activities including:

  • Understanding the voice of the customer and documenting the user needs
  • Developing comprehensive product specifications
  • Analyzing and managing risk
  • Developing meaningful, validated test methods

Medavise engineers have extensive experience in navigating and managing all aspects of the design control process, from initial technology research and assessment, preclinical test development and coordination, failure mode assessment, risk analysis and mitigation as well as overall project management within the typical phase-gate system. In addition, our engineers have significant experience and training in process and manufacturing engineering as well as in R&D, assuring your product is developed with a keen eye toward manufacturability.


– Clinical investigation
– Post-market surveillance
– User survey
– Clinical Evaluation Report (CER)


– Regulatory strategy
– Ongoing support
– Labeling
– 510(k), PMA, EU, ROW submissions

Quality & Engineering

– eQMS
– Ongoing support
– Design History File (DHF)
– Internal & vendor system audits

technical services

– Biostatistics
– Literature review
– Manuscript preparation