Engineering SupportA good regulatory submission starts with good engineering documentation.
Are you creating engineering documentation twice? Once during design and development and a second time when you compile information for your regulatory submission? Our team of experienced engineers can help with the development of the mechanical, electromechanical, and software documentation required to successfully create a Design History File and support a regulatory submission or technical file. We don’t just have the engineering knowledge; we also know what the FDA and Notified Bodies will be looking for in a submission.
We provide a comprehensive portfolio of engineering services:
- Design Control process development
- Design History File remediation
- Risk Management
- Software documentation development
- eQMS software validation
- Usability – Human Factor testing
- Sample Size selection
- Cyber Security audit
- Process Validation
- Testing facilitation (sterilization, biocompatibility, IEC 60601)
- Compliance training
Developing a comprehensive yet useful design control process is can be very challenging, especially for a start-up. Many companies struggle to ascertain when to start design controls and how much documentation is required. MEDIcept engineers have worked at start-ups and know exactly what the authorities are looking for. Let us develop or review your current process—we can make sure it is streamlined and compliant.
Have you created a device you think is ready for submission, but the FDA tells you that your Design History File (DHF) does not contain enough evidence to prove the product was designed correctly? Our team of multi-disciplinary engineers can help reconstruct your design documents and create a compliant DHF. Whether it is software or hardware, internet-connected wearable technology, or plain surgical instruments, our engineers have the experience.
Documenting software to meet IEC 62304 can be challenging, especially when iterative software development is used. We have experience in Agile development as well as today’s tools like Jira and Team Foundation. We can help you create a lifecycle process that creates the documentation while you generate the code, so you are always in compliance.
Do you have any software you are using to meet your quality management system, like eQMS software? We can help ensure compliance is 21CFR820.70(i). We can help develop a Software Master File and have the expertise to help validate all the required software systems.
Do you need to perform a Usability Study? We have human factor experts who can help with protocol development, implementation, FDA meetings, and report writing.
FDA and Notified Bodies require validated manufacturing processes. Historically, if you said the process was 100% verified, you did not need validation. Now, the authorities want you to prove it. 100% visual inspection, even 100% functional inspection, may not be adequate anymore. Our team can help develop, train, and execute process validations or write proper justifications to meet the expectations.
Sometimes the workload is too much, or sometimes there is no in-house expertise on a particular topic. Our engineers have experience in many facets of development. From ASTM standards to gamma or EtO sterilization to biocompatibility to electromechanical safety to package and ship testing. We can help with the protocol development and interfacing with the testing houses. We have relationships with many third-party testing facilities, and we can use them to get better pricing and timing.
I need help NOW!
Is your engineering department bogged down and the window of opportunity closing fast? We can provide the innovative engineering support you need to jumpstart your project now.
Need FDA or EU MDR/IVDR audit assistance?
Don’t go it alone. Our deep, firsthand experience with FDA and EU MDR/IVDR audits can help you minimize risk and business disruption.
Are you a start-up?
Do you lack the resources to quickly and effectively develop your first product and get it to market? We have the engineering firepower to bolster your efforts and ensure a high-quality medical device gets launched in a timely manner.