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.

Rescisco Global Regulatory Consultants > Trainings & Qualification

Trainings & Qualification

Build the Regulatory Capability Inside Your Organisation.

The best regulatory strategy is one your team understands and owns. Our training programmes are designed not just to deliver certificates, but to build genuine regulatory competence — the kind that prevents costly mistakes before they happen and enables your team to navigate audits with confidence.

"An organisation where every product development engineer understands basic regulatory requirements is an organisation that designs compliance into the product from the start. That is the most cost-effective quality investment a manufacturer can make."

— Rescisco Global, Training Practice

Our Training Programmes

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Indian Medical Device Regulations (IMDR)

Comprehensive overview of MDR 2017, device classification, CDSCO licensing requirements, SUGAM portal operations, and post-market surveillance obligations under Indian law.

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Risk Management for Medical Devices

ISO 14971:2019 implementation training — risk analysis, risk evaluation, risk control, residual risk assessment, and production/post-production activities. Practical workshop format.

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US FDA Medical Device Regulations

21 CFR Parts 820 (QMSR), 801 (labelling), 806, 803, and 807 — with a focus on 510(k) preparation, predicate strategy, and FDA audit readiness.

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ISO 13485:2016 — QMS for Medical Devices

Awareness, implementation, and internal auditor courses. Covers the full QMS standard with practical examples for device manufacturers at different scales and complexity levels.

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EU MDR 2017/745 & IVDR 2017/746

Transition and implementation training covering Article 10 obligations, Annex I GSPR, clinical evidence requirements, EUDAMED, and Authorised Representative responsibilities.

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IEC 62304 — Software Lifecycle Processes

Training for software development teams on IEC 62304 requirements, software safety classification, V&V documentation, SOUP management, and cybersecurity integration.

6+Regulatory Curricula
Online &In-Person Delivery
CustomCorporate Programmes
CPDCertificate on Completion
All training programmes are available as open-enrolment public courses or as customised on-site corporate workshops tailored to your product category, quality system maturity, and target market requirements.

"The strongest medical device companies in the world share one trait: they see regulatory expertise not as a cost of doing business, but as a strategic investment in patient safety and market leadership. At Rescisco Global, that investment is what we protect — every day, for every client."

— Rescisco Global Regulatory Consultants, Hyderabad