We, Rescisco Global Regulatory consultants, intended to offer quality and regulatory services to the manufacturers of medical devices including in-vitro diagnostic medical devices from conceptualization stage to marketing as per the requirements.
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Documentation, Auditing & Certifications
Your Documents Are Your Regulatory Reputation.
In the medical device world, your Technical File is your product's biography — every claim, every test result, every design decision must be coherent, traceable, and defensible. We build documentation systems that don't just pass audits. They inspire confidence.
"A poorly structured Technical File doesn't just delay approval — it signals to regulators that your quality culture has gaps. We ensure your documents tell the story of a manufacturer who takes quality seriously."
— Rescisco Global, Documentation Practice
Quality Management Systems
- ISO 13485:2016 QMS gap analysis and full implementation
- ISO 9001:2015 for non-device healthcare operations
- MDSAP-ready quality system design
- SOP library development and document control systems
- Management review and CAPA system design
- Supplier qualification and vendor audit programmes
- Internal audit training and conduct
Technical Documentation
- EU MDR Annex II & III Technical Documentation
- Design History File (DHF) and Device Master Record (DMR)
- Risk Management File (ISO 14971:2019)
- Clinical Evaluation Report (CER / ISO 14155)
- Post-Market Surveillance Plan and PSUR
- Summary of Safety and Clinical Performance (SSCP)
- Biological evaluation documentation (ISO 10993 series)
ISO Standards We Support
ISO 13485:2016ISO 9001:2015ISO 14971:2019ISO 10993 SeriesISO 14155:2020ISO 15189:2022ISO 11607-1/2ISO 45001:2018ISO 14001:2015ISO 50001:2018IEC 60601 SeriesIEC 62304:2015IEC 62366-1:2015