Regulatory-Ready Quality Leadership
From early-stage documentation to notified body inspections, Dang C&C Services embeds disciplined quality, regulatory, and risk expertise so MedTech innovators can move confidently toward clearance.
Quality Systems Leadership
Sequel Medical • Polaris AR • Inter Science • SabbaMed
Designs, authors, and sustains ISO 13485, 21 CFR Part 820, and MDSAP-aligned quality management systems for venture-backed medical device teams.
- Fractional quality leadership for rapid scale-ups and global teams.
- Tailored SOP suites, document control, and workforce training programs.
- Internal audit preparation and remediation ahead of notified body visits.
Regulatory Strategy & Submissions
Syntactx • BrainCool • UROCAM • GenMark Diagnostics
Partners with regulatory affairs to accelerate FDA 510(k), EU MDR/CE Marking, and international submissions for class II and III combination products.
- Compilation of technical documentation and regulatory dossiers.
- Bridges design control, clinical, and manufacturing data for approvals.
- Lifecycle support for post-market surveillance and change control.
Risk Management & Product Safety
Vactronix Scientific • CryoLyse • IdealMed • ImmunSYS
Implements ISO 14971 risk processes that align R&D and operations around proactive hazard mitigation and CAPA performance.
- Leads FMEA/FMECA workshops and traceability across product lifecycle.
- Establishes complaint handling, vigilance, and field action pathways.
- Conducts cross-functional CAPA, supplier, and internal audit programs.
Detailed Capabilities
We translate complex regulatory expectations into actionable plans. Explore how our core competencies align with your development stage.
Quality Management
- ISO 13485 Compliance Programs
- 21 CFR Part 820 Readiness
- MDSAP Audit Preparation
- Document Control Systems
Regulatory Affairs
- FDA 510(k) & De Novo Submissions
- EU MDR & Global Registrations
- Technical Documentation Authoring
- Post-market Surveillance Plans
Risk Management
- ISO 14971 Process Deployment
- FMEA / FMECA Facilitation
- CAPA & Supplier Quality Programs
- Complaint Handling & Vigilance