Our Work
Navigating changes to medical device regulatory requirements for market access in major markets such as the US and EU can be daunting. We partner with clients to provide expert interpretation of regulatory requirements, guidance documents and relevant standards. Here is a guide of our some of our services.
Regulatory Consulting Services
EU MDR/CE marking
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Preparation and review of technical documentation for Notified Body submissions
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Management of correspondence with Notified Bodies during technical file review
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Labeling review to ensure compliance with EU MDR requirements
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Regulatory intelligence to stay updated with evolving EU regulations
US FDA Pre-Market
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Preparation of 510(k) submissions
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Development of regulatory strategies for successful commercialization
US FDA Post-Market
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Complaint handling and Medical Device Reporting (MDR)
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Warning Letter and Form 483 response support
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Remediation planning and CAPA management
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Creating medical device reporting processes in line with 21 CFR Part 803
Quality Management Systems Consulting
Medical Device Risk Management
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SoTA (State of the Art) assessment to meet EN ISO 14971 standards
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Risk management across the product lifecycle for new product development
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Risk management file review and remediation
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Creation/review of risk management policies and procedures
Device Lifecycle Management
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Application of risk-based methodologies to post-market data analysis and trend reporting
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Implementation of processes for complaint handling and escalation
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Detection of device design or manufacturing flaws through comprehensive analysis
Design Control
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Review and improvement of design and development processes
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Establishment of effective change control processes, ensuring thorough impact analysis