The Sterling Guarantee
With Sterling as your Medical Device Development Partner, you are assured:
- Experience. We have a full-time, permanent engineering staff, guaranteeing you consistent personnel, focused expertise, and a wealth of experience. Every team member brings to the table both breadth and depth in their field, ensuring the job is done right.
- Efficiency. We bring you the best practices and tools you need to manage costs, reduce risk, and stay on schedule as you bring your product to market.
- Flexibility. We employ a flexible approach to best meet your needs. We can integrate our team with yours, or we can work independently from concept through testing. We will be there when you need us.
- Openness. We operate with transparency and inclusion throughout the entire development process. This is done by providing frequent status, detailed time reporting, and access to interim work product for review.
- Innovation. We work with your team to spawn new ideas employing our experience with the most current regulatory compliance know-how. We also free up your in-house team’s time and capacity, allowing them to pursue innovative endeavors.
- Leverage. You are welcome to leverage our ISO 13485-registered, IEC 62304 and IEC 60601-compliant quality system while we help you bring your own quality system online, as well as our extensive IT infrastructure. This gives you the opportunity for a fast ramp up, speeding your product to market.
- Tools and Equipment. We utilize the most advanced, modern development tools and test equipment for the enhanced quality needed to produce safety and mission-critical devices while preserving efficiency.
- Risk Focus. To ensure a successful project and regulatory compliance, Sterling maintains a diligent focus on risk throughout the development life cycle.
- Compliance. We focus on what is necessary and essential. Our proven regulatory acumen of what auditors are seeking consistently leads to the right choice of processes and deliverables, avoiding the risk of rejection and promoting both FDA and EU success.
- Conscientiousness. Our team understands how important your goals and timelines are. That’s why we work to reduce development time and cost while ensuring the highest quality product.
- Testing. We believe testing should not be taken lightly. We employee people who love to test, who love to “break things”. We also understand testing is expensive so we believe in “picking the weeds instead of mowing them down with the grass”. Our test philosophy is geared to provide you with the confidence and evidence that your system is performing as required.
- Ownership. Right from the start, you will have the peace of mind of knowing when a project is finished; you will own all the intellectual property and deliverables.
… and Commitment:
At Sterling, we stand ready to partner with you in any phase of your medical device development. We will help you bring your newest product to market, troubleshoot a challenging technical issue, or optimize development processes for your specific needs. Our goal is to exceed your expectations. Our philosophy is simple: we do what it takes to make you successful.