QES Medical LLC

Quality & Regulatory Consulting

Who We Are and What We Do

QES Medical LLC is a consulting firm, founded in 2009, providing a variety of quality, regulatory and software development consulting services to the medical device industry, as well as to the pharmaceutical industry.

We help companies achieve and maintain QMS certification; software life cycle processes; cGMP; and product regulatory clearance.

We have vast experience helping both, small and large companies, which give us the perspective and ability to help clients based on their specific needs, always ensuring that clients receive compliant and adequate services. Contact us today and see what we can do for you.

Get to Know Us

Oscar Garcia

Founder and President

18+ years of experience in the medical device industry, including large companies, such as Abbott Laboratories and Covidien (now Medtronic), as well as small start-up companies.
Engineering and business background, including quality and regulator leadership roles in medical device start-up companies, such as Common Sensing in Cambridge MA, where Oscar held the role of Quality Director.
Hands on QA/RA contributions to successful medical device start-up companies, such as Corindus Vascular Robotics, acquired in 2019 for $1.1 billion dollars and Lumendi, which launched its first medical device product in 2016.

Our Services

Quality Management Systems

QMS Development and Support

We can help you develop and maintain your Quality Management Systems in accordance with the applicable standards and regulations, including ISO 13485, FDA QSR 21 CFR part 820, 21 CFR part 210/211 and 21 CFR part 4. We can work on a project basis, or we can engage in short or long terms quality team contracts to help you achieve your objectives. Contact us today by booking your desired service shown below.

Design Control

Support Design and Development Activities

We can help you plan, develop and maintain your design control documentation for all your design and development activities in accordance with the applicable standards and regulations, including ISO 13485:2016 and FDA 21CFR820 Sec. 820.30, as well as IEC 62304 - Medical Device Software Compliance and IEC 62366-1 - Usability Engineering. We can work on a project basis, or we can engage in short or long terms quality team contracts to help you achieve your objectives. Contact us today by booking your desired service shown below.

Risk Management

Risk Management Process and Risk Management File

We can help you develop or upgrade your risk management process. We can also plan, develop and maintain your product risk management file in accordance with the applicable standards and regulations, including ISO 14971:2019. We can work on a project basis, or we can engage in short or long terms quality team contracts to help you achieve your objectives. Contact us today by booking your desired service shown below.

QMS Audits

Audit Readiness Planning

We have vast experience preparing teams to successfully host audits. Benefit from our expertise and let us help your team learn and use effective techniques, which will allow your company to be ready for your upcoming QMS audit. We can work on a project basis, or we can engage in short or long terms quality team contracts to help you achieve your objectives. Contact us today by booking your desired service shown below.

Training

Training and Educating your Staff

We have a variety of training sessions in key processes, such as Design Control and Risk Management, as well as in the entire Quality Management Systems. These trainings are ideal for those companies, or individuals, who are looking to implement, upgrade or better understand these processes and their application on their product. Contact us today by booking your desired service shown below.

Other Services

General Support

We offer other services to help you achieve your objectives. These include cleanroom services (on-site microbial air and surface environmental monitoring services for cleanrooms); QMS audits and remediation, including combination product compliance per 21 CFR part 4 and 21 CFR part 210 / 211; medical device software life cycle processes and activities; supplier control management; implementation of electronic QMS platforms per ISO 13485, FDA QSR 21 CFR part 820 and 21 CFR part 11; among others. Contact us today by booking your desired service shown below.