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More than a Quality Management System: Tools for the entire MedTech Lifecycle.

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Featured Capabilities:

Document Management Training Management CAPA Management Audit Management Product Development

Experience the #1 QMS software for medical device companies first-hand. Click through an interactive demo.

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Accelerate development with integrated design control and risk software.

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Featured Capabilities:

Design Controls Risk Management Risk Intelligence

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Data collection and management designed for MedTech clinical trials.

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Featured Capabilities:

Electronic Data Capture (EDC) Electronic Case Report Forms (eCRF) Electronic Patient Reported Outcomes (ePRO) Ad-Hoc Data Collection (Cases) Post-Market Surveys Product Add-Ons

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$600 FREE TOOL

Clinical Evaluation Toolkit

All medical devices sold in the EU market require a clinical evaluation and a clinical investigation in order to prove the product is safe for the intended users and achieves what the manufacturer claims the device was designed to do.

Use this toolkit to complete your:

  • Clinical Investigation Plan
  • Clinical Investigation Report
  • Clinical Investigation Application Form
  • Investigator’s Brochure

This powerful toolkit is originally priced at $600, but is being offered to you for free by Simplimedica, the developer of the toolkit and a trusted partner of Greenlight Guru.

This free Clinical Evaluation Toolkit will help you:

  • Understand the requirements for clinical evaluation and investigation of your product(s)
  • Complete a variety of clinical evaluation documentation
  • Ensure compliance with EU MDR 2017/745

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Simplimedica Clinical Eval Toolkit (2)

What's included with this tool:

  • Downloadable zip folder containing multiple useful files
  • Customizable template to complete a variety of clinical evaluation documentation
  • Instructions for use of the toolkit
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SIMPLIMEDICA-LOGO-WITH-TAGLINE (1)

About Simplimedica

Simplimedica is a consultancy firm that believes in long-term partnerships. We support short-term, medium-term, and long-term project work for small medium-sized businesses as well as large corporations. You may have a shortage in skill or wish to outsource some work that may be more productive. Simplimedica has experience in a number of Pharmaceutical and Medical Device companies.

Adnan Ashfaq is a Quality, Regulatory & Validation Specialist with almost 20 years of experience in the Medical Device, Biotech, and Pharmaceutical industries. Adnan founded Simplimedica in 2011 and has since supported Medical device companies around the labyrinth of regulations and assisting them in flying through successful audits. He has worked with start-up companies and multinationals to develop new products since 1999. With regulations tightening, especially in Europe, Simplimedica enables and simplifies the compliance conundrum to ensure manufacturers reach their desired market and stay in the market.

Visit their website to learn more.


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About Greenlight Guru

Greenlight Guru provides the leading cloud-based solutions for MedTech companies to bring life-changing products to people faster, and with less risk.

Greenlight Guru provides purpose-built quality management, product development, and clinical data management solutions that together help teams accelerate timelines, streamline compliance, and deliver high-quality products.

With Greenlight Guru, companies across the globe are improving efficiency, speed, and quality in every aspect of their organization to get products to market faster and keep them on the market longer.

SMART-TRIAL by Greenlight Guru is the leading clinical data collection toolbox, purposefully built for MedTech. Collect and manage clinical data in pre and post-market clinical studies, including registries, cohorts, surveys, human factor testing, design validation, and more.

SMART-TRIAL meets the regulatory requirements of the FDA, EU, and most other countries, and ensures compliance out-of-the-box with GCP and ISO 14155:2020.

Visit our homepage to learn more.