EXPERTISE
Pre-Compliance Gap Analysis
Remove uncertainty from your compliance journey
Bringing a medical device or product to market requires meeting strict regulatory standards. Our Pre-Compliance Gap Analysis service is tailored to alleviate this burden by systematically evaluating your product’s design, documentation, and processes against relevant standards. This proactive approach uncovers discrepancies that could lead to non-compliance, allowing for timely corrections and reducing the risk of costly delays during formal compliance testing.
At eg technology, we work closely with your team to review your design, code, documentation, and processes against the relevant regulatory requirements, including ISO 13485, IEC 60601, ISO 14971, IEC 62304 and more. This ensures a thorough assessment that aligns with your product and market sector.
Streamline your product’s compliance
Our team of experts brings a wealth of experience across various sectors, including medical devices, laboratory equipment, and consumer products. We conduct thorough assessments that align with your specific product and sector requirements. Our service includes:
Design
Evaluation
We review your product design against applicable specifications to ensure it meets the necessary standards.
Risk Assessment
Analysis
We assess your risk management documentation, including Failure Modes and Effects Analysis (FMEA), to identify potential hazards and ensure comprehensive mitigation strategies are in place.
Pre-Compliance
Testing Review
If you’ve conducted any pre-compliance testing, we evaluate the results and provide recommendations for improvement.
Documentation Review
Our team examines your existing documentation for alignment with relevant standards, such as:
- IEC 60601 for medical device electrical safety & performance
- IEC 61010 for laboratory equipment & IVD electrical safety
- IEC 62304 for medical device software development
- IEC 62366 for medical device usability and human factors
Benefit from early insight and proceed with confidence
Engaging in our Pre-Compliance Gap Analysis offers several advantages:
Early Detection of Issues
Identify and address compliance gaps before they become significant problems, reducing the risk of delays during formal testing phases.
Cost Efficiency
By resolving potential compliance issues early, you can avoid the expenses associated with redesigns or repeated testing.
Streamlined Development
Our analysis provides clear guidance on necessary adjustments, helping to keep your development process on track and within budget.
Regulatory Confidence
With our thorough assessment, you can approach formal compliance testing with greater assurance, knowing that potential gaps have been addressed.
Maximise your chance of product success
With years of experience in product development, we understand what it takes to achieve compliance efficiently. Our structured approach helps you mitigate risks, streamline approvals, and avoid last-minute surprises.
Partner with eg technology for your Pre-Compliance Gap Analysis and ensure a smoother path to product approval and market success.
We can tailor any Gap Analysis based on your needs and budget and as such, the estimate for our review package will depend on the scope of the review and any budget constraints.
"*" indicates required fields