Engineering based analysis starts your project off right.
Research Based Analysis
Solutions Engineering can help you develop comprehensive technical research specific to your prospective device.
Planning and Specification Process
Solutions Engineering can assess and recommend technologies relevant to your product and assist in the development of detailed technical specifications for your project.
Assisting in the clarification of relevant standards
Solutions Engineering clarifies relevant standards up front for maximum efficiency.
Solutions Engineering develops a rapid, yet thoughtful, big picture design before committing to a specific electronics design. This helps get the project rolling in the right direction early to keep your timeline on track.
Step by Step
Solutions Engineering develops a rapid, yet thoughtful, big picture design before committing to a specific electronics design. This helps get the project rolling in the right direction early, lowering the technical risk, maintaining your timeline.
Solutions Engineering has become established as industry experts in embedded software design for medical devices. We have done everything from simple, small, low powered devices to complex, number crunching DSP software design. Of course, we do all this in compliance to IEC62304 and FDA Guidance.
Solutions Engineering has a proven record of design excellence in Analog and Digital Electronics including a wide range of experience in:
• sensors (including pressure sensors, temperature sensors, biochemistry sensors, optical sensors, and Doppler sensors),
• low power devices,
• battery operated devices, and
• wireless devices.
Design for Regulatory Compliance
Solutions Engineering is well versed in regulatory compliance and can, therefore, cater their design to best meet these requirements.
Design for Manufacturability
When you have the industry experience that Solutions Engineering has, you have the ability to assist your clients in developing a design that is regulatory compliant, while simultaneously optimizing your ability to manufacture your device.
Quick Turn Prototyping
Physical results you can touch, test, and tweak.
Solutions Engineering's quick turn prototyping throughout the design process ensures incremental testing of technical feasibility and allows rapid feedback to the team, management, and investors.
Prototyping for Clinical Trials
Solutions Engineering has a proven track record in providing assistance in this pivotal phase by providing early clinical trials device compliant to Quality and Regulatory requirements.
While Solutions Engineering does not provide large scale manufacturing, we do work with you to determine the best manufacturer for your product and ensure that manufacturing meets all design criteria. This continuity of support ensures smooth transitions and quick completions from Design Transfer to field support.
Testing Specific to Your Product Needs.
Using the power of a virtual environment, Solutions Engineering is able to test the validity of preliminary designs.
Solutions Engineering supports certified lab testing in safety, EMC, and wireless.
Verification and Validation (V&V)
We integrate verification and validation into the design process (rather than tack it on to the end) to allow smooth flow through the design process.
FDA and EN Standards Compliant
Solutions Engineering has a long history of FDA- compliant and MDD-compliant product development. We use a mature, cost effective approach with maximum flexibility and minimum bureaucracy.
Design History File
Solutions Engineering will provide the critical items for your Design History File. Providing the needed components of your Design History File is integral to our process.
Quality systems support
Already have a quality person on your team? Solutions Engineering offers support services to your quality engineer to ensure project compliance.
Industry Complexities Knocked Down to Size.
Using years of experience in the regulatory environment, Solutions Engineering is able to systematically reduce the extent of exposure to risk in the engineering component.
Design History File
Solutions Engineering will provide the critical items for your Design History File.
Design to IEC60601 and IEC62304 Compliance
Solutions Engineering leverages its years of exerience in IEC60601 and IEC62304 compliant designs to plan compliance into your project's design process from the very start.
Audited Design Control and Documentation Methods
Solutions Engineering's design process and documentation protocol is audited to State-of-the-Art best practices to minimize customer cost.
Verification and Validation (V&V)
We integrate verification and validation into the design process (rather than tack it on to the end) to allow smooth flow through the engineering process.
by your side.
From ensuring the engineering design meets regulatory and manufacturability standards to full scale quality system management, Solutions Engineering can run the technical aspects of your medical device development project.
Are you interested in technical help during the clinical trials phase? Solutions Engineering has a proven track record in providing assistance in this pivotal phase.
Do you have an existing product that is in need of modernized technology and electronics? Solutions Engineering can assist you in the process of upgrading your device to meet current design standards and FDA compliance.