At CriTech, we are not just a software engineering company; we are your partners in innovation and compliance. I’m Bob Rajewski, founder and president, and I’m thrilled to share our journey and the incredible work we do.
Since 1994, CriTech has been at the forefront of medical device software development, testing, and cybersecurity. Our team of over 30 software engineers, many of whom have been with us for over a decade, brings a wealth of experience and a deep understanding of the industry. We have worked with a diverse range of clients, from start-ups to the largest corporations in the medical device industry, and we are proud to say that every time our work has been submitted by our customers, the FDA and EU have approved it the first time. We are immensely proud of our 100% first-time approval record, and it is a testament to our commitment to quality and compliance.
Here is what you can expect when you work with us.
A Highly Responsive Team
- Sometimes new clients are surprised when my team and I hop on a plane and show up in person for a meeting. We take your projects and challenges seriously.
- Our timelines are based on decades of experience, which means we commit to the milestone dates, testing gates, and final delivery we promise.
Custom Solutions
- We understand that every medical device project is unique.
- We offer custom solutions tailored to your specific needs, whether you require software development, verification and validation, cybersecurity, or software remediation.
True Independent V&V
- Our independent verification and validation processes ensure that your software meets the highest standards, eliminating any conflicts of interest.
- This independence is crucial in maintaining the integrity of the testing process and ensuring that your products are safe and effective.
A Cost-Effective Approach
- We are committed to providing services that are not only high-quality but also cost-effective.
- Our goal is to help you manage your budget while ensuring that your products meet all necessary regulatory requirements.
- Our quote is rarely the lowest, but it is always highly accurate, so you can stay on budget.
Expertise in All FDA Device Classes and IEC 62304
- Our extensive experience with products from all FDA device classes and IEC 62304 software safety classifications means that we can handle any project, no matter how complex.
- This breadth of knowledge allows us to provide comprehensive support throughout the entire development process.
Dedicated and Experienced Team
- Our team of over 30 software engineers, many of whom have been with us for over a decade, brings a wealth of experience and expertise to every project.
- This continuity ensures that we maintain a high level of quality and consistency in our work.
State-of-the-Art Facilities
- Our headquarters in Saline, Michigan, and our second facility in San Jose, Costa Rica, are equipped with the latest technology and resources.
- These facilities are designed to support our engineers in delivering the best possible results for our clients.
ISO 13485:2016 Certified
- Our ISO 13485:2016 certification is a mark of our commitment to quality and compliance.
- It ensures that our processes and products meet the highest international standards.
We’re excited about the future and the opportunities it holds. In fact, we’ve created Lighthouse Studios inside our headquarters to better deliver quality training and thought leadership content to our customers and prospects. So be on the look out for many more videos in the year ahead. It is an exciting time to be part of the medical device industry, and we are honored to be your partners in this journey.
If you are looking for a team that is dedicated to excellence, innovation, and compliance, think CriTech. We are here to help you achieve your goals and bring your medical device software to market with confidence. Contact us today to learn more about how we can help you. Let us make remarkable things happen together
Bob Rajewski
Founder & President