Quality

A strong quality system is the foundation of lasting success.

Pillars

Quality  |  QMS Design and Implementation

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.  Both will serve as a foundation to successfully support nearly all the operation functions of your medical device company.

Medavise has partnered with greenlight.guru to provide clients with a cloud-based eQMS system uniquely designed for small medical device businesses.  While paper-based systems can still be made to work for smaller-scale operations, their use and maintenance can quickly become a burden once the business is up and running.  This is especially true for virtual device companies which utilize off-site staff and consultants for routine operations.  Greenlight.guru offers an electronic-based QMS system that can ease compliance to quality regulations while using a core module built from the ground up to efficiently handle design control needs.

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Quality  |  Auditing

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 analysis of QMS documentation, full or partial internal QMS audits, and supplier audits.

Quality  |  Complaint Investigation

Our expertise and problem-solving extends beyond a successful regulatory clearance. Experienced Medavise engineers can work with your staff and advising clinicians to coordinate and perform device failure analysis as part of a complaint investigation, an integral part of your ongoing risk management plan.

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Our client is a new “virtual” company developing its invention for use in gastroenterology.  Medavise was engaged to take the Class II product from final design through FDA clearance. Because the client intends to market the device under its own name, Medavise installed a paper-based QMS for the client with the electronic master files stored online.  We started with the document and design control systems to capture User Needs and early design work to help build the design history file and jump-start the risk analysis effort.  This client will be a good candidate for upgrading to an eQMS system after its first round of outside investment.

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Our client is an emerging orthopedics device company that runs lean so it can put more resources towards expanding sales.  The Director of Quality has a solid grip on the QMS but needs help with routine internal and critical supplier audits.  Medavise works with the client to perform these audits, present the findings and recommend changes that will not only assure compliance but also improve system performance.

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Our client is a spinal device manufacturer with devices that had been explanted during revision surgery.  The client requested Medavise to supervise the physical analysis of the explants and report on the results.  We worked with a local engineering lab with a global reputation to perform scanning electron microscopy (SEM) and differential interference contrast (DIC) optical microscopy to reveal device surface changes. Additional digital microscopy and high resolution macro photography were performed by Medavise to augment the images recorded by the engineering lab. This analysis provided the client the information they needed to properly evaluate the event and submit a report to the regulatory agency with proper evidence to support their conclusions.

Success: starting at the beginning and focusing on the basics.Learn More
Ensuring success by using valid evidence to tell the story.Learn More
A strong quality system is the foundation of lasting success.Learn More
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