,Choose the Right Toolkit for Your Device Class
Freyr’s customizable Medical Writing Toolkit is a comprehensive, class-specific documentation suite aligned with EU MDR 2017/745 and EU IVDR 2017/746 and designed to evolve with your Regulatory journey. Our tiered Basic, Standard, and Premium Kits offer scalable support for Class I–III Medical Devices and Class A–D IVDs. Whether you’re launching a new product or maintaining compliance for a high-risk device, the toolkit addresses every Regulatory requirement across Clinical Evaluation, Performance Evaluation, and Post-Market Surveillance (PMS).
Customize Your Toolkit for Maximum Compliance
Choose from variant options or entire toolkits for tailored documentation solutions
Build Your Own Toolkit
Choose from individual templates like CER, PER, SSCP, PMS Plans, and more, ideal for manufacturers with specific gaps in documentation
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Tailored Documentation: Choose from a broad catalog of Clinical Evaluation, Performance Evaluation, and PMS templates.
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Flexible Compliance: Designed for both Medical Devices and IVDs across all risk classes—aligns seamlessly with your EU MDR/IVDR needs.
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Cost-Efficient: Pay only for what you use. Select specific templates or SOPs to create a focused, budget-friendly solution.
Go Kit-Based for Simplicity
Select from Basic, Standard, or Premium Kits depending on your device classification. Pre-bundled for Regulatory alignment and ease of setup.
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End-to-End Documentation: Kits include Clinical/Performance Evaluation + PMS components, ensuring complete lifecycle coverage.
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Expert-Authored Templates: All kits are developed by experienced Regulatory writers to meet stringent compliance standards.
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Efficient, Bundled Access: Avoid scattered purchases. Our kits deliver structured, ready-to-deploy documents.
Medical Devices Toolkit
| Kit Type | Templates Included | Ideal for |
|---|---|---|
| Basic Kit | CEP, CER, PMS Plan, PMS Report | MDR Class I / IIa |
| Standard Kit | Basic Kit + PSUR, LSR, Clinical Evaluation SOP & PMS SOP | MDR Class IIb |
| Premium Kit | Standard Kit + SSCP, PMCF Plan & Report | MDR Class III / Implantable Devices |
In Vitro Diagnostic Devices Toolkit
| Kit Type | Templates Included | Ideal for |
|---|---|---|
| Basic Kit | PEP, PER, PMS Plan, PMS Report | IVDR Class A / B |
| Standard Kit | Basic Kit + PSUR, LSR, Performance Evaluation SOP & PMS SOP | IVDR Class C (non-high-risk) |
| Premium Kit | Standard Kit + SSP, SVR, CPR, APR, PMPF Plan & Report | IVDR Class C (high-risk) & D |
Benefits of the Toolkit
Class-Based Toolkit Options:
Basic, Standard, and Premium for MDVs and IVDs
Fully Customizable:
Choose only the templates you need
Regulatory Aligned:
Built for EU MDR 2017/745 and IVDR 2017/746
Expert-Curated and Ready-to-Use
Scalable & Cost-Effective Documentation Approach
Meet Our Medical Writing Experts
Sindhuri Manubolu
Manager, Medical Writing
Sindhuri brings over 11 years of experience in medical writing, with deep expertise across the medical device and in vitro diagnostic (IVD) sectors. She oversees end-to-end clinical documentation projects for Medical Devices. She leads cross-functional teams, ensures Regulatory compliance, and drives process optimization through SOP and template development. With a strong focus on quality, team leadership, and client engagement, Sindhuri consistently delivers strategic, compliant, and timely medical writing solutions.
Dr. Radhika Ramachandran
Senior Manager, Medical Writing
Dr. Radhika Ramachandran holds a Doctorate in Biotechnology and is a Certified Medical Writer and Trainer. She brings over 12+ years of experience across R&D, academia, and regulatory medical writing. She has authored and reviewed content for national and international journals and has developed 1000+ clinical and regulatory documents for medical devices and IVDs, including CERs, PERs, Summary Documents, Post-Market Documents and more.
Frequently Asked Questions on Clinical &
Performance Evaluation Toolkit
Depending on your selection (Basic, Standard, or Premium), the toolkit includes documents such as Clinical/Performance Evaluation Plans and Reports, PMS Plans, PSURs, SOPs, SSCP/SSP, and more.
Basic Kits cover essential documents for Class I/IIa (MDV) or Class A/B (IVD). Standard Kits include safety updates and SOPs. Premium Kits offer full coverage, including summary and post-market follow-up reports for high-risk classes.
Yes, you can fully customize your toolkit by selecting only the documents you need. This allows you to create a personalized package that aligns with your Regulatory requirements and saves costs by avoiding unnecessary components.
Yes, all templates are aligned with EU MDR 2017/745 and IVDR 2017/746 requirements.
Our expert team is available to guide you in selecting the right documents based on your product type (MDV or IVD), Risk Classification and Regulatory needs. We ensure that your chosen toolkit is optimized for compliance with EU MDR 2017/745 and EU IVDR 2017/746. You can reach out to us at sales@freyrsolutions.com.
The Clinical Evaluation Toolkit is designed for medical devices (MDV) and focuses on meeting the EU MDR 2017/745 requirements, while the Performance Evaluation Toolkit is for in vitro diagnostics (IVD) and complies with EU IVDR 2017/746. Both toolkits include specific SOPs, plans, and reports tailored to these respective regulations.
Need More Than Templates? Get End-to-End Regulatory Support
Leverage our team's deep Regulatory expertise to navigate complex medical device requirements, ensuring risk mitigation and tailored solutions for full EU MDR and IVDR compliance. Explore our Regulatory solutions for Medical Writing by clicking here.
Seasoned Regulatory Experts
Freyr has a proven track record of successfully delivering complex projects for medical device companies, including CEP/R, PEP/R, CPRs, SVRs, and PMS-related tasks. Our extensive experience ensures that we understand the intricacies of Regulatory requirements and can guide you through every step.
Tailored Solutions
We offer customized services that address your specific device and Regulatory needs, ensuring full compliance with EU MDR 2017/745 and EU IVDR 2017/746. Our personalized approach guarantees that you receive the exact support you need.
Broad Product Expertise
With extensive experience across a wide range of product categories, from Class I devices to IVDs and Software as a Medical Device (SaMD), Freyr has the knowledge and expertise to handle any product type. This broad expertise allows us to provide comprehensive support for diverse Regulatory challenges.
Risk Mitigation
We proactively identify potential challenges and offer solutions to ensure your submissions meet all Regulatory requirements. Our strategic approach minimizes compliance risks and enhances the likelihood of successful submissions.
