Medical Device Consulting Services

Medical Devices in a Modern World

Medical devices are present in almost all aspects of life; they are everywhere. As technology continues to improve and drive the world we live in, medical devices and their associated technologies are evolving as well. Although these developing technologies have led to significant advancements in modern medicine, they have also made it increasingly more challenging from a regulatory perspective.

That is where we enter the equation – CALPROMED is here to help you with all matters concerning the regulation and compliance of your medical device or combination product.

CALPROMED’s Comprehensive Medical Device Consulting Capabilities

CALPROMED is a full-service FDA consulting firm that provides an all-inclusive medical device service offering. Our consulting capabilities include all regulatory and compliance aspects of device and combination product development. We have experience with medical devices across all classes spanning a diverse range of indications.

CALPROMED consulting expertise is built upon our in-depth knowledge of the medical device manufacturing industry and our expertise in devising effective compliance strategies. By partnering with us, manufacturing enterprises are directed on how to implement effective solutions that drive business objectives and establish trust with clients.

Guiding Compliance Through All Stages of Manufacturing

From design to development to testing, CALPROMED directs quality, compliance, and regulatory efforts at each phase of the manufacturing process. Our experience allows us to assist with devising proactive strategies that include compliance awareness throughout a project, rather than as a bolted-on addition.

CALPROMED’ consulting expertise can provide practical and efficient guidance in the following areas:

  • Regulatory and 510k submissions
  • Comprehensive validation, covering devices, processes, and software
  • Full remediation programs
  • Unique Device Identification (UDI)
  • EU Medical Device Regulation (MDR) Compliance
  • In Vitro Diagnostic Regulation (IVDR) Compliance
  • Meeting manufacturing compliance in foreign markets
  • Risk management
  • Handling new product regulatory applications
  • Development and creation of Clinical Evaluations Reporting (CER)
  • CE Marking
  • Corrective Action/Preventive Action (CAPA) procedures, GxP validation, and the necessary documentation
  • Restriction of Hazardous Substances (ROHS) concerns, such as tin-based solder issues
  • Testing requirements
  • Complaints and recalls

Medical device manufacturers are contributing to healthcare achievements around the world, and in order to ensure that safe and dependable instruments are being produced, CALPROMED delivers customized strategies that balance business goals with patient safety.

Medical Device Consulting Experts

Regardless of where you are in the development or approval of your medical device, we can help. We take a proprietary approach to the FDA, combining deep and broad scientific knowledge with extensive regulatory experience. This method has proven successful for decades, as we have assisted our clients in achieving FDA approvals for the past 35 years. It is our emphasis on science, coupled with the technical expertise of our medical device experts, that allows us to effectively communicate with the FDA on their wavelength in support of your product.

CALPROMED can help with all regulatory and compliance aspects of your medical device. Contact us today to learn more about our qualifications and experience with medical devices and combination products.