GEAR UP YOUR
INNOVATION
ANYTHING IS POSSIBLE
QA/RA services for MD, IVD, and SaMD companies
Our solutions ensure:
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A scalable, audit-ready QMS that supports innovation
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Fully documented development from concept to release
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Faster, smoother paths from idea to market
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Streamlined systems that ease resource pressure
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Lower risk, quicker decisions, stronger compliance
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More predictable projects with fewer iterations
Building an eQMS in MS 365 or GOOGLE Drive Environment
2C has developed an MS365-based eQMS for CSF-Dynamics A/S, manufacturer of Non-Active Implantable Medical Devices- that was certified by DEKRA. The customizable system uses familiar MS365 or Google Drive tools such as Word, Excel to meet standards like ISO 13485, without the subscription costs of traditional eQMS platforms available on the market.
QMS Services (QA)
2C delivers QMS consulting, implementation, and maintenance for ISO 13485 and FDA QMSR (21 CFR 820). We help MD, IVD, and SaMD companies create and maintain fully compliant quality systems, covering gap analysis, process design, documentation, and audit preparation for certification, surveillance, and re-certification. Our support embeds strong risk management and regulatory compliance across the entire product lifecycle, from design to post-market.
Regulatory AffairS Services (RA)
2C provides Regulatory Affairs services to help medical device, IVD, and SaMD companies navigate global requirements and bring products to market compliantly. We support regulatory strategy, technical file preparation, FDA and CE submissions, interactions with notified bodies, and post-market surveillance. Our expertise covers MDR, IVDR, ISO 14971, IEC 62304, IEC 60601, ISO 10993, usability, software and cybersecurity guidance, ensuring compliance throughout the entire product lifecycle.
Audit Services
We provide audit services to help companies meet ISO 13485, FDA QMSR, and EU MDR/IVDR requirements. We perform internal audits, technical file audits, supplier audits, and product audits, and support companies during notified body certification and surveillance audits. Our audits confirm that QMS processes are effective, risks are controlled, and organizations are ready for regulatory inspections, reducing the risk of non-compliance, recalls, or certification problems.
Bringing Medical Device Ideas to MARKET (SystemS Engineering)
2C has developed a range of IVD and non-active implantable medical devices for multiple clients. We use a structured, step-by-step development process that takes a product from concept to market, defining user needs, planning, prototyping, testing, managing risks (ISO 14971), and ensuring compliance with FDA, EU MDR, and ISO 13485. Every stage of design, verification, validation, transfer to manufacturing, and PMS is thoroughly documented in a Design History File (DHF).
ISO 9001 Quality Management System
2C supports companies in building, implementing, and maintaining ISO 9001 Quality Management Systems. Our services help organizations improve product and service quality, streamline operations, reduce waste, manage risks more effectively, and demonstrate a strong commitment to quality, leading to higher customer satisfaction, greater efficiency, and a stronger competitive edge.
ISO 14001 Environmental Management System
2C supports organizations in implementing and maintaining ISO 14001:2015 Environmental Management Systems. We help improve environmental performance by optimizing resource use, reducing waste, and building stakeholder trust, strengthening overall competitiveness. A new revision, ISO 14001:2026, is expected to be released in 2026.
ISO 45001 Occupational Health and Safety Management System
2C helps organizations implement and maintain ISO 45001:2018 Occupational Health and Safety Management Systems. This standard, which has replaced OHSAS 18001, supports companies in creating safe, healthy work environments through proper risk assessment, employee training, emergency preparedness, and continuous monitoring and improvement.