Medical Device Engineering Support

Crafting a thorough and effective design control process poses significant challenges. Determining the right time to initiate design controls and gauging the extent of necessary documentation can be daunting tasks. At MEDIcept, our engineers boast firsthand experience working with large, medium and small-sized medical device manufacturers, providing us with invaluable insights into regulatory expectations. Allow us to lend our expertise to assess gaps and either tailor or review your existing design control processes, ensuring alignment with regulatory standards while streamlining operations for optimal efficiency and compliance.  

Do you have a device you believe is ready for market clearance, only to be informed by the regulatory agency that your DHF/Technical Documentation lacks sufficient evidence to demonstrate its proper design? Our team of versatile engineers can assist in reconstructing your design documentation to meet compliance standards. Whether it involves software or hardware, internet-connected wearables, or traditional surgical instruments, our engineers possess the requisite expertise to remediate in a timely manner.

Drafting software documentation to align with IEC 62304, IEC 82304 and IEC 81001-5-1 standards can pose challenges, particularly in scenarios involving iterative software development. Leveraging our expertise in Agile methodologies and contemporary tools such as Jira and Team Foundation, we help establish a secure software development lifecycle process to set you up for success. This approach ensures seamless documentation generation alongside secure code development, ensuring continuous compliance. MEDIcept can help structure your cybersecurity and AI/ML development processes, develop threat models, secure your software supply chain and build the cybersecurity portion of your regulatory submission.  We even offer gap assessments and mock audits to help surface latent issues with your software-based devices.  

Do you need to design and conduct a usability study? Our team of human factors experts excels in protocol development, implementation, discussions with regulatory agencies, and report writing, ensuring comprehensive assistance throughout the process. 

Are you currently utilizing software for your quality management system, such as eQMS software? We specialize in Computer System Validation and Computer Software Assurance. Our services include the development of a Software Master File and expertise in validating all necessary software systems. 

Regulatory agencies around the world require validated manufacturing processes. Historically, if you said the process was 100% verified, you did not need validation. That no longer works – you must prove it. 100% visual inspection, even 100% functional inspection, may no longer be adequate. Our team can help develop, train, and execute process validations or write proper justifications to meet expectations. 

At times, the workload can become overwhelming, or there may be a lack of in-house expertise in specific areas. Our engineers boast expertise across various development facets, ranging from ASTM standards to gamma or EtO sterilization, biocompatibility, electromechanical safety, and packaging and ship testing. We offer support in protocol development and liaising with testing facilities. Leveraging our extensive network, we can facilitate better pricing and timing for you through collaborations with numerous third-party testing facilities.