Medical Device Engineering Support
A good regulatory submission starts with good engineering documentation.Are you duplicating your efforts by generating engineering documentation twice? First during the design and development phase, and then again when compiling information for regulatory submission?
Are you unsure how to address new cybersecurity or AI/ML regulatory requirements for your device?
Are you remediating your Design History File (DHF) and/or Technical Documentation (design & development documentation) in response to audit or inspection findings?
Our adept team of experienced engineers are ready to step in to streamline the compilation process by assisting in the creation or updating of mechanical, electrical, and software documentation necessary to establish and maintain a comprehensive DHF/technical documentation set to bolster your regulatory submission or technical file.
Whether this is your first device submission or just the latest in a long line of successful submissions, MEDIcept can scale a solution to help you meet the regulatory requirements of your target market(s).
We provide a comprehensive portfolio of engineering services:
- Gap Assessments
- Design Control Process Development
- Design History File / Technical Documentation Remediation
- Product Safety Risk Management
- Software Documentation Development
- Threat Modeling
- Product Cybersecurity Risk Management
- SBOM Construction
- Coordinated Vulnerability Disclosure Process Development
- Incident Response Process Development
- Cybersecurity process development
- Artificial Intelligence / Machine Learning (AI/ML)-based Device Development
- Predetermined Change Control Plans
- Software as a Medical Device (SaMD) Submissions
- Human Factors / Usability Engineering
- Compliance Testing Facilitation (sterilization, biocompatibility, IEC 60601, IEC 61010)
- Design Controls, Risk Management and Cybersecurity Training
- Process Validation
- Computer System Validation / Computer Software Assurance including eQMS
Design Control
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.
Remediation
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.
Risk Management
Are you confident that your medical device designs are the safest and most secure solutions available? Can you demonstrate compliance to ISO 14971 and ISO/TR 24971? What about cybersecurity risk management standards ANSI/AAMI SW96 and ANSI/AAMI TIR57/TIR97? If your device includes AI or ML facilities, have you considered the potential safety and security risks outlined in AAMI CR34971? MEDIcept’s quality engineers can help you build compliant processes and risk management files no matter what type of risks are relevant to your devices.
Software, Cybersecurity, and AI/ML
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. 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.
Usability Engineering
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.
Automated Processes
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.
Process Validation
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.
Compliance Testing
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 through collaborations with numerous third-party testing facilities.