Our Industries

We expertly assist clients with quality and regulatory needs in multiple life science industries. We service:

Medical Devices

Medpoint helps medical device makers ensure the safety and efficacy of their products. With our deep understanding of the industry, including ISO 13845:2016, MDSAP, EU MDR, and much more, we guide clients through the maze of requirements so their products meet all standards. We also help identify and fix issues with design and development.

In addition, our global team of regulatory experts can guide your team in entering new markets around the world. Our expertise and dedication make us a trusted partner for medical device developers.

Contact us for additional information or to request a quote from the Medpoint team.

Pharmaceutical

We assist pharmaceutical companies with regulatory compliance, quality management, performance, validation, and clinical affairs. Medpoint helps these companies maintain high standards and comply with regulations by implementing a robust QMS. We also audit processes and suppliers to ensure they’re compliant and find areas for improvement. Our comprehensive gap analyses identify QMS issues and develop strategies to address them effectively.

In addition to quality management, we’re dedicated to ensuring drug quality. For this purpose, we write SOPs and work instructions, and offer supply chain oversight. With our expertise and commitment, pharmaceutical companies maintain the highest standards.

Get in touch with the Medpoint team today for a quote or more information.

Biotechnology

Medpoint is a valuable partner for biotechnology companies, helping them with regulations, process audits, training, and more. Our team of biotech experts helps clients comply with ever-evolving regulations, developing strategies to meet the necessary standards and guidelines.

Biotechnology companies often face complex safety considerations and our experience in risk assessment and safety protocols mitigates potential hazards. We also offer technical troubleshooting so nothing holds our clients back from realizing their products’ potential. Our team of experts diligently investigates and resolves problems, ensuring seamless operations and minimizing downtime. Furthermore, we conduct process audits to identify areas for improvement, optimize efficiency, and enhance quality control measures to keep things flowing smoothly. 

Contact the Medpoint team today for additional information or to request a quote.

Diagnostics

Diagnostics play a vital role in disease treatment and management. Access to diagnostic and monitoring technology improves people’s quality of life and reduces preventable deaths. Medpoint proudly supports clients in the diagnostics industry with quality assurance and regulatory affairs, bringing expert level knowledge in Good Laboratory Practices (GLP) and a robust pool of consultants.

As part of our specialty diagnostics services, we develop Quality Management Systems (QMS) based upon GLP guidelines for clients to mitigate risk and ensure quality. With robust QMS strategies, clients improve their operations and achieve regulatory compliance. Our mock inspections and other process tests help our clients stay compliant and operate effectively. They identify areas of improvement and we ensure procedures are in line with industry standards. Finally, our training programs empower our clients to continually enhance their skills and knowledge, contributing to their overall success.

Interested in learning more? Contact us to request a quote from the Medpoint team.

CLIA Labs

All lab tests on humans in the U.S. are subject to the Clinical Laboratory Improvement Amendments (CLIA) and regulated by the Centers for Medicare & Medicaid Services (CMS). Such strict regulations require an in-depth understanding of regulations and standards, and how to build operations successfully around them. Medpoint shares this expertise with our clients through our many quality assurance, regulatory affairs, and clinical affairs services.

Implementing a Quality Management System (QMS) is crucial for keeping CLIA labs on track with quality and compliance. We help labs find improvement opportunities and mitigate risks with gap analyses and testing. Our audits and mock inspections safeguard lab operations by identifying non-compliance or potential issues. As a result, our clients’ processes and procedures align with industry standards. In addition, we provide dedicated technical support and thorough training so CLIA labs operate effectively and efficiently. 

Contact the Medpoint team to request a quote or more information.

Food

Medpoint plays a crucial role in assisting food industry companies with successful business by ensuring adherence to regulations and improving overall performance. Our dedication to our clients’ safety and quality standards helps them avoid legal issues and penalties, and build trust and credibility with customers.

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We expertly validate our clients’ processes and implement quality management systems. We put them to the test with audits and assessments, finding areas for improvement and optimizing operations. This leads to increased efficiency, reduced waste, and enhanced product quality. Our comprehensive training programs keep our clients informed and well-trained, avoiding disruptions, minimizing risks, and fostering continuous success.

Ready to request a quote or have questions? The Medpoint team is here to help. Contact us today.

Agriculture

Our goal is to help the agriculture industry companies produce safe, quality products that comply with regulations. Medpoint offers a range of consulting services to make sure our clients meet the highest standards of quality assurance, regulatory affairs, and supply chain management. The agriculture industry regulatory landscape can be complex and full of obstacles. With our experts, you’ll avoid expensive problems and inconvenient downtime.

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We also provide comprehensive technical support and training to attain long-term success. Providing companies with knowledge and skills to maintain and improve their feed production processes is important to us. From guidance to running quality systems, we can handle everything while you focus on your core business.

Contact the Medpoint team for more information or to request a quote.