Medical Device Manufacturing & Packaging Solutions
Medical device development and manufacturing requires a comprehensive understanding of equipment manufacturing, automation, testing, and product hardware/software verification. A high degree of expertise is absolutely essential in verifying hardware, software, and manufacturing products such as glucose monitors, heart rate monitors, combination injection devices, or other medical devices classified under 21 CFR Part 8XX level regulations. The medical device manufacturing industry demands strict adherence to safety and quality manufacturing protocols, and may be one of the most evolving and complex manufacturing environments in the world today.
Failure to comply with regulations can lead to potentially disastrous results for a medical device manufacturing company. Clarke Solutions is focused on protecting your company and customers, and preventing damage to your products, services, and brand. Clarke Solutions is focused on preventing medical device manufacturing issues by focusing on improving all aspects of development and manufacturing. We recognize that very few medical devices are identical and that very few solutions in this field are “off the shelf.”
Clarke has dedicated hardware and software testing teams that focus solely upon medical device product testing, prior to pre-approval/pre-release stages. This extensive process requires a specific skill set to successfully prepare the hardware and software under critical timelines, which are often key in meeting market demand.
Clarke’s highly experienced engineers ensure that your manufacturing equipment and automation solutions fit your needs, and that testing and validation are complete. This also includes serialization and new product scale up for your medical devices. And, although we rely heavily on process and technology, it’s still all about the people. Clarke Solutions’ specialists work together with you and your teams to fully resolve your medical device manufacturing challenges.
Clarke Solutions offers you the gift of security.
Medical Device manufacturers give the gift of life, or a better quality of life, through their products. Clarke Solutions offers you the gift of security—security in the knowledge that Clarke Solutions’ field -experienced engineers will be there from the start—during product and equipment design, automation, testing/validation, all the way to the successful launch of your medical device.
Clarke Solutions delivers comprehensive medical device manufacturing solutions. If you need a medical device industry specialist, contact us here or call 317.849.0330 today for a free, no-obligation assessment of your medical device manufacturing needs.