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Understand the regulations, standards, and certification requirements applicable to your products. Discover how iRM and our expert services simplify regulatory research and support your product certification journey.

Overview

iLenSys Regulatory Intelligence & Certification combines the iLenSys Regulatory Master (iRM) platform with expert regulatory intelligence and product certification services, helping organizations identify applicable regulations, standards, certification requirements, and critical component information for their products and target markets throughout the product development lifecycle.

By bringing regulatory intelligence software, expert research, and certification services together, organizations can reduce manual research, make informed product decisions earlier, streamline certification activities, and accelerate entry into global markets with confidence.

Who We Serve

iRM supports every team responsible for product regulatory readiness across the product lifecycle.

Regulatory Affairs Teams

Regulatory Affairs Teams

Stay ahead of global regulations with centralized monitoring, alerts, and a comprehensive regulatory library.

Quality Assurance Teams

Quality Assurance Teams

Ensure products align with applicable standards and certification requirements throughout development.

Engineering Leads

Engineering Leads

Validate product designs against applicable regulations early in development to avoid costly redesigns.

Regulatory Analysts

Regulatory Analysts

Access a searchable library of global standards and updates for accurate impact assessments.

Product Managers

Product Managers

Oversee product development and market launches with confidence by anticipating regulatory risks and component challenges.

Testing & Certification Teams

Testing & Certification Teams

Coordinate certification activities, manage critical component requirements, and streamline product certification with expert support.

How It Works

iRM brings global regulatory intelligence and critical component management together in one platform. Explore its key capabilities:

Regulatory Library Manager

Regulatory Library Manager

Access a centralized repository of global regulations and standards, with curated updates, news, and guidelines that impact your products and markets.

Global Market Access Search

Global Market Access Search

Access curated regulatory requirements and standards for your products and target markets, enabling faster research and informed market expansion decisions.

Dashboards & Analytics

Dashboards & Analytics

Visualize regulatory trends and component risk status with real-time dashboards. Generate exportable reports (PDF/CSV) and share insights across teams.

Critical Component Manager

Critical Component Manager

Centralize critical component information, applicable standards, and certificates to support regulatory compliance and product certification.

Regulatory Impact Guideline

Regulatory Impact Guideline

Understand the regulatory impact on critical components with expert-curated guidance to support informed design and certification decisions.

Why Choose iRM

Key differentiators of our solution include:

Comprehensive Regulatory Intelligence

Comprehensive Regulatory Intelligence

Unlike point solutions, iRM combines a structured regulatory library and critical-component monitoring in one platform.

Quick Access to Relevant Standards

Quick Access to Relevant Standards

Search and filter regulations specific to your products and target markets for faster decision-making.

Proactive Risk Management

Proactive Risk Management

Identify high-risk components early and plan actions before regulatory changes disrupt your design or supply chain.

Expert-Curated Regulatory Intelligence

Expert-Curated Regulatory Intelligence

Access product- and market-specific regulatory requirements researched and curated by our regulatory experts, enabling accurate and reliable decision-making.

Actionable Dashboards & Analytics

Actionable Dashboards & Analytics

Visualize regulatory trends and component risk status with intuitive dashboards and exportable reports.

Scalable & Future-Ready

Scalable & Future-Ready

Designed to evolve with expanded markets, new regulations, and seamless integrations.

Expert Compliance & Certification Services

Beyond software, our specialists deliver end-to-end regulatory compliance and product-certification support.

Regulatory Services

Regulatory Impact Assessments

Regulatory Impact Assessments

Detailed evaluations of how regulatory changes affect your products and operations.

Compliance Strategy for New Product Development

Compliance Strategy for New Product Development

Assistance in developing compliance strategies for new products.

Country-Specific Certification Support

Country-Specific Certification Support

Help with meeting the regulatory requirements of different countries.

Dedicated Customer Support

Dedicated Customer Support

Tiered support including direct access to product-safety engineers and account managers.

Regulatory Compliance Consultation

Regulatory Compliance Consultation

Expert advice on meeting regulatory requirements.

Regulatory Update Reports

Regulatory Update Reports

Regular reports on changes in regulations relevant to your industry.

Quality & Compliance Services

Regulatory Affairs Consultation

  • Compilation of regulatory dossiers
  • Gap analysis of documentation
  • Remediation planning
  • Compliance to harmonized standards

QMS Remediation

  • Proactive monitoring of regulatory changes, supplier quality, CAPA system
  • QMS gap assessment and SOP updates

Biocompatibility & Sterilization

  • Biocompatibility evaluation
  • Toxicological assessment
  • Disinfectant validation
  • Sterilization process validation

IVD-Specific Support

  • Performance evaluation plan and report compilation
  • Establish scientific-validity claims by literature search

CE Marking & Product Certification Support

  • Gap analysis & construction review
  • Third-party lab testing to standards
  • Critical component lists & test-report review
  • Documentation and user-manual review

Product Certifications We Support

Our regulatory and product certification services support a wide range of global certification programs and country-specific requirements.

CE (MDR/IVDR)

CE (MDR/IVDR)

CE conformity for medical devices and IVDs, including technical files and MDR/IVDR transition support.

FCC

FCC

FCC Declaration of Conformity for electromagnetic-interference limits on products sold in the US.

CB Scheme

CB Scheme

International product-safety certification accepted across 50+ countries via the IECEE CB Scheme.

ICES

ICES

Interference-Causing Equipment Standard compliance for ISM, IT and digital equipment.

OSHA NRTL

OSHA NRTL

Nationally Recognized Testing Laboratory certification for US electrical safety standards.

In-Country Regulatory Support

In-Country Regulatory Support

Support for country-specific regulatory registrations, documentation, and compliance requirements to help bring products to global markets.

Get a Custom Quote

Let's Discuss Your Project

Your personally identifiable information is not shared with any third-party without your explicit permission, unless we are required to do so by law. To learn more about our privacy practices, please refer to our Privacy Policy.

Unveil the Potential of iRM

Unlock the full potential of regulatory compliance with iRM — your comprehensive solution for navigating complex regulatory standards with ease and precision. iRM is not just software; it's the key to mastering compliance and gaining a competitive edge.

Book a Demo

Frequently Asked Questions

What is iLenSys Regulatory Master (iRM)?

iLenSys Regulatory Master (iRM) is a regulatory intelligence platform that helps organizations identify applicable regulations, standards, certification requirements, and critical component information to support product development and global market readiness.

Which modules does iRM include?

iRM includes the Regulatory Library Manager, which provides access to curated regulations, standards, and market-specific requirements, and the Critical Component Manager (CCM), which helps manage critical component information, certificates, applicable standards, and regulatory impact guidelines.

How does iRM differ from iCM?

iRM focuses on regulatory intelligence, standards research, certification support, and critical component management, while iCM helps organizations collect product compliance data and assess compliance against environmental regulations such as RoHS, REACH, PFAS, etc.

Can iRM support products entering new global markets?

Yes. Our regulatory experts research and curate the applicable regulatory requirements for your specific products and target markets. This information is then made available through iRM, helping teams simplify regulatory research and prepare for global market entry.

What analytics and reporting capabilities does iRM offer?

iRM provides dashboards and reports that help teams monitor regulatory updates, analyze regulatory impacts, and share insights across engineering, quality, and regulatory teams.

Do you provide regulatory and product certification services?

Yes. In addition to the iRM platform, iLenSys provides expert regulatory and product certification services, including regulatory impact assessments, product certification support, regulatory affairs assistance, QMS remediation, and CE Marking support to help organizations meet global regulatory requirements.

Is iRM scalable and ready for future regulatory expansion?

Yes. iRM is designed to scale with your business, supporting additional products, target markets, and evolving regulatory requirements.

News & Updates

The "News & Updates" section features the latest developments and innovations across our services and solutions, including Engineering Services, Product Lifecycle & Compliance (Product Environmental Compliance, Product Sustainability, Regulatory Intelligence & Certification, Obsolescence Management), and Integrated Capabilities.

View all News & Updates
Achema 2024 Event
Regulatory Intelligence & Cert 10 Jun 2024

The ACHEMA, Modern, interactive and always up to date: With a unique range of topics, exciting innovations and new event formats, the world's leading trade show for the process industries brings together experts, decision makers and trendsetters from all over the world.

Read More
AIAG 2026
Product Environmental Complian 07 Oct 2026

AIAG IMDS, Product Compliance & Sustainability Conference

Read More
PSX 2026
Product Environmental Complian 20 Oct 2026

We invite you to be part of this vibrant gathering of professionals who are driving progress across industries and around the world.

Read More

Resources you might be interested in

Blogs
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In many organizations, compliance is treated as a final checkpoint—something to validate once the product design is complete. Engineering teams focus on functionality, performance, and cost, while regulatory considerations are often addressed closer to certification or market entry.

View Blog
Whitepapers
ilr-Guide to Choose the Right Protection Concept for Your Product.jpg

HAZLOC Product focuses on ensuring compliance with international standards for hazardous locations (HazLoc). It highlights the importance of identifying and selecting the appropriate protection concept, a critical step in mitigating risks associated with explosive atmospheres.

View Whitepapers
Webinars
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How leading organizations are shifting from reactive compliance to proactive regulatory management

View Webinar
Videos
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Discover how iLenSys Regulatory Master simplifies regulatory complexity and helps you manage critical components with confidence.

View Videos
Case Studies
ilr-critical-component-manager.jpg

The iLensys Regulatory Master serves as a critical component manager, overseeing essential elements for product safety and diligently addressing the risk of regulatory non-compliance.

View Case Studies
Newsletters
ilr-irm-3.jpg

We highlight the mandatory implementation of EUDAMED (European Database on Medical Devices) and what it means for manufacturers operating under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

View Newsletters
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iLenSys Technologies Pvt. Ltd.

8-2-293/82/L/231/ABC,
MLA Colony, Road No: 12, Banjara Hills,
Hyderabad, Telangana 500 034
Phone: 040 – 66998246, 040 – 66998234
Email: info@ilensys.com