Consulting and Advising on Medical Device regulation
Expert guidance for smooth regulatory compliance
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Expertise for Certification and Regulatory Success
We simplify medical compliance, guiding device manufacturers and healthcare providers through key standards like ISO 13485, ISO 14971, and regulations such as MDR, IVDR, HIPAA, GDPR, and FDA.
We design customized solutions—from platforms for clinical trials to workflow optimization and advanced data analytics—always upholding the highest standards of security.
Certification Path
Navigating Certification Processes
We assist your company in understanding and progressing through each stage of certification, ensuring alignment with all relevant standards and requirements.
Step-by-Step Support
Our team offers expert guidance through certification processes such as ISO 13485, ISO 9001, and other standards, reducing obstacles and streamlining the path to compliance.
Regulatory Strategy and Planning
Tailored Approach
We develop customized regulatory strategies that help ensure your software medical products comply with applicable regulations.
Comprehensive Guidance
With a team of experts, LifeLogic provides full support to interpret and apply MDR, IVDR, HIPAA, GDPR, and FDA regulations in everyday operations. Our guidance minimizes risk and prevents potential non-compliance issues.
Regulatory Navigation Support
Documentation Assistance
We offer professional help in preparing and submitting necessary documentation for regulatory approvals, including 510(k) submissions, PMA (Pre-Market Approval), and CE Marking applications..
Accelerated Approval Process
Our services expedite the time needed to secure certifications and approvals, enabling quicker market entry.
Why LifeLogic?
Compliant Market Launch
Ensure your products meet all regulatory and quality standards for a smooth market introduction
Streamlined Certification
Simplified processes save time and resources, accelerating your time to market
Risk Reduction
Avoid costly delays or rejections with expert guidance and precise documentation
Operational Excellence
Enhanced efficiency and security through strict compliance and accurate documentation
Proven Expertise
Benefit from our in-depth knowledge and years of experience in medical software regulation
Innovation Focus
Let us handle compliance, allowing you to concentrate on innovation and business growth
Ensure Compliance, Accelerate Approval
Let’s connect and explore how we can be the ideal partner for your company!
