+1 (707) 5618 771
info@rmt-usa.com
Guidewell Innovation Center, Orlando, FL, USA
Regulatory & Quality Compliance Trainings

HIPAA Compliance
Learn how to design, handle, and manage healthtech products in accordance with U.S. HIPAA regulations. This workshop covers patient data protection, electronic health record (EHR) security, and breach mitigation strategies.

ISO 13485
Master the requirements and implementation of ISO 13485 for quality management systems in medical device manufacturing. From documentation to internal audits, this course prepares you for certification and real-world compliance.

ISO 14971
Understand the lifecycle-based risk management process for medical devices under ISO 14971. This training includes risk analysis tools, mitigation strategies, and integration into your design control process.

ISO 62304
This software lifecycle standard is critical for SaMD and embedded systems. Gain a complete understanding of software development processes under ISO 62304 and how to implement it in clinical-grade applications.

ISO 27001
Our ISO 27001 training helps healthtech organizations protect sensitive health data by establishing, implementing, and managing information security management systems (ISMS).

GMP Compliance
Get trained on Good Manufacturing Practices (GMP) specific to medical devices and pharmaceuticals, including cleanroom behavior, documentation control, and audit preparedness.
Engineering & Product Development Trainings

Design Control & Management
This program guides you through FDA and ISO requirements for design controls, including inputs/outputs, verification/validation, and DHF/DHR documentation.

FMEA & DFMEA
Understand Failure Mode & Effects Analysis (FMEA) and its design-focused variant (DFMEA) for identifying potential failures and optimizing reliability during early-stage development.

Healthtech Workforce Training
We provide targeted upskilling programs for healthcare engineers, product managers, and QA professionals to adapt to evolving technologies, standards, and clinical environments.
Research & Entrepreneurship Modules

Research Methodology
Ideal for clinical and product researchers, this workshop covers protocol design, ethics, data analysis, and publication strategies aligned with regulatory expectations.

Entrepreneurship in Healthtech
Designed for physician-led startups and innovators, this module focuses on taking an idea from concept to commercialization — covering IP strategy, clinical validation, and early product planning.

Business Plan & Technocommercial Feasibility
Learn to evaluate your healthtech concept through the lens of market need, regulatory landscape, competitive analysis, and financial viability — culminating in a pitch-ready business plan.
Scientific & Laboratory Skills Workshops

HPLC (High-Performance Liquid Chromatography)
Gain practical training in analytical method development and validation using HPLC for pharmaceutical and biomaterial analysis.

UV Spectrophotometry
Hands-on workshop on UV-visible spectroscopy techniques used in compound quantification, drug purity assessment, and formulation validation.

Drug/API Synthesis
Learn lab-scale synthesis, characterization, and purification techniques for active pharmaceutical ingredients (APIs) and novel drug candidates.

Pharmacokinetics & Pharmacodynamics
Explore the fundamentals of drug absorption, distribution, metabolism, and excretion (PK/PD), with real-world case studies in formulation and delivery optimization.
Regulatory & Quality Compliance Training:
Engineering & Product Development Trainings:
Research & Entrepreneurship Modules:
Scientific & Laboratory Skills Workshops:
Our Expertise

Product
Design & Development

Testing &
Validation

Regulatory Strategy
& Consulting

Medical-Grade
Manufacturing & Scale-Up

Quality Management
& Compliance
Let’s Talk


Hop on a discovery call
Let's start by understanding your business. In our initial conversation, we'll explore your team setup, project goals, timeline, budget, and required expertise to see how we can align.

Identify the right solution together
We'll shape the project plan, figure out the best way to collaborate, and select the perfect team to get things moving.

Get started and accelerate fast
Once we've got the plan in place, we'll dive in. You'll get regular updates, and we'll keep things flexible, adjusting as we go to tailor to your needs.
Your complete journey partner from conceptualisation to Full-Scale Commercial Reality in the Medical Innovation Landscape.
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