Design and implementation of regulatory compliance systems is a major area of focus for Syprosoft Engineering. We have worked on all aspects of mandated quality systems and processes. For details, click on the buttons above.
We have also helped our clients obtain marketing clearance for new products including PMA and 510(k).
MEDICAL DEVICE Regulations
Medical devices are regulated by the FDA and other jurisdictions based on patient risk. The higher the risk the greater the mandates. Class I devices need to comply with general controls including registration, listing, labelling & good manufacturing practices. Class II devices are subject to special controls including performance, guidelines, pre-market data and surveillance. Class III devices require pre-market approval (PMA) by the FDA. There are three important aspects involved in regulatory affairs as described below.
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REGULATORY Clearance
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Regulatory clearance is obtaining permission for new product sales. Syprosoft Engineering guides clients in navigating the clearance pathway. For high risk devices a cumbersome PMA may be needed. At the other end, some devices are exempt from any filing. The majority fall in between. If the client’s device can be shown to be “substantially equivalent” to a previously cleared device (“predicate”) then a relatively simple traditional 510(k) applies. If no predicate exists a more complex de novo process applies. Note that “substantially equivalent” is not the same as “significantly equal”. This is an opportunity to diminish the claims for the new product to make it substantially equivalent to a predicate. Once clearance is obtained the client may be able to use its own product as a predicate to expand the claims via a special 510(k).
Regulatory Compliance
Regulatory compliance is adherence to an quality system. For new products, this includes planning, risk management, requirements, specifications, design descriptions, design output, verification and validation. Syprosoft Engineering helps clients comply with the latest regulations. We put together systems that are customized to the client’s operations and add only minimal burdens. We design processes that are not only compliant with the regulations but also appropriate to the size of the client thus minimizing compliance costs.
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Regulatory Efficiency
- Regulatory efficiency is performing clearance and compliance activities at minimum cost. This aspect is often overlooked specially by regulatory consultants. Efficiency makes a large difference in the profitability of the business, both large and small. It is inefficient clearance and compliance activities that lead to such horrors:
- “We have 8 employees in the company and 61 SOPs”
- “It takes up to 6-8 weeks to get a change order approved”
- “It cost more to verify and validate than it cost to design the product”
- “We spend two weeks just training new hires on our multitude of forms”
- “We fear audits as our employees don’t understand our own quality system”
None of this is necessary. Regulations may appear onerous, but in reality they provide some leeway. A system appropriate for a large company is probably not suitable for a small company and certainly not advisable for a start-up. Yet some clients get saddled with a cumbersome system advocated by regulatory consultants. Syprosoft Engineering designs systems suitable for the size of its clients and which are scalable. We drill down to the principles underlying the regulations and interpret the regulatory text in a customized manner to design an efficient system for you. Our clients save money while receiving regulatory clearances and passing compliance audits!
PMA and 510(k) EXPERIENCE
Syprosoft Engineering has extensive knowledge of the stringent regulatory requirements for higher risk medical devices including PMA, De Novo, and 510(k). We have helped clients implement quality processes to comply with the latest regulations. Even a small start-up has to have a quality system that is compliant with the regulations including cybersecurity. One way to minimize regulatory burdens is to use a risk based approach. We have helped our clients prepare risk assessments by using both production data and published literature. We also follow many IEC and ISO standards and FDA guidance in our work. Below are examples of some products that we developed the verification and validation (V&V) plans, performed the tests and prepared PMA and 510(k) filings.
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Trans-Myocardial RevascularizationQualified an upgraded cardiac laser by using efficacy tests. Demonstrated no impact on creation of myocardial channels during TMR thus supporting a successful PMA Supplement filing.
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SPECT Image Analysis Designed algorithms for processing liver/spleen scans to determine liver function. Developed V&V protocols and reports for a successful 510(k).
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Blood Processing Developed some of the software and performed V&V for a blood collection and processing system. Prepared protocols/reports for a 510(k) filing.
Implanted Cardio Assist PumpDeveloped risk based test protocols at the unit, integration and system levels for V&V of this PMA device. Tested and documented in formal reports.
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Orthognathic SurgeryPrepared FDA documentation for an orthognathic surgery planning system including a positioning splint. Successfully obtained a 510(k) clearance.
Intra-operative AberrometerFormulated the software V&V plan and wrote the test protocols. Prepared test reports for a successful 510(k) filing.
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Stroke TherapyDeveloped the GUI and embedded control software for a system to treat ischemic stroke using low-level infra-red laser therapy. Prepared V&V documents for this PMA device.
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StimulatElectrical ionPerformed verification and validation and prepared a 510(k) package for a successful clearance for this device to treat viral cold sores.
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Vital Signs MonitorDeveloped V&V plan, test protocols and reports for an innovative bed-sheet sensor based vital signs monitor for a 510(k) filing.