Who We Are

Rico Solutions India Private Limited is a globally recognized compliance and certification consultancy headquartered in India, with a sharp focus on the medical devices and healthcare sector. We specialize in offering end-to-end regulatory consulting services that empower manufacturers to successfully navigate the stringent requirements of the EU MDR 2017/745, achieving EC Certification seamlessly and efficiently.

With a strong team of regulatory experts, biomedical engineers, quality auditors, and documentation specialists, we provide holistic support that aligns your medical devices with global regulatory expectations—especially those mandated by the European Commission under the MDR framework.

Why EC Certification Under MDR (EU 2017/745) Is Crucial

The transition from the Medical Device Directive (MDD 93/42/EEC) to the Medical Device Regulation (EU 2017/745) represents one of the most significant regulatory overhauls in recent years. The MDR enhances clinical safety, strengthens product traceability, and demands a higher standard of clinical evaluation and post-market surveillance.

To legally market your product in Europe, obtaining EC Certification under MDR is now mandatory for most Class I (sterile/measuring), Class IIa, IIb, and Class III devices. This certification, issued by a notified body, verifies that your device complies with essential health and safety requirements and can carry the CE marking.

At Rico Solutions India Private Limited, we act as your strategic compliance partner to streamline the complex journey of EC Certification and ensure your product’s readiness for the European market.

Our Core Services for EU MDR (2017/745) Compliance

We offer comprehensive support covering every aspect of MDR compliance and EC Certification. Our services include:

1. Regulatory Strategy Development

We help you determine the best regulatory pathway for your medical device based on its risk classification, intended use, and regulatory jurisdictions. We also support regulatory gap assessments to identify non-compliances and areas of improvement.

2. Technical Documentation Preparation

Under MDR, technical files must include detailed information such as risk management, design verification, biocompatibility, and clinical evaluations. Our experts assist in compiling and organizing all required technical documentation in line with Annex II and III of the regulation.

3. Clinical Evaluation Report (CER)

One of the most critical and challenging parts of MDR compliance is demonstrating clinical evidence of safety and performance. We prepare robust Clinical Evaluation Reports (CERs) based on MEDDEV 2.7/1 rev. 4 and MDR Article 61, ensuring they meet notified body expectations.

4. Quality Management System (QMS) Implementation – ISO 13485:2016

An effective QMS is essential for MDR compliance. We help implement and maintain ISO 13485:2016 systems, ensuring alignment with Article 10 of MDR and creating a strong foundation for regulatory approval.

5. Notified Body Liaison

We facilitate smooth interactions and submissions to notified bodies for your EC Certification audits. We support you during audits, corrective action closures, and certification processes.

6. Post-Market Surveillance (PMS) and Vigilance

Our team assists in establishing robust PMS plans and periodic safety update reports (PSURs). We also guide you on managing Field Safety Corrective Actions (FSCAs), trend reporting, and compliance with EUDAMED submissions.

7. UDI & EUDAMED Support

We help you generate Unique Device Identifiers (UDI) and register your devices on the European Database on Medical Devices (EUDAMED) to ensure traceability and transparency.

Industries and Product Categories We Serve

Our EC Certification and MDR services cater to a wide range of medical device manufacturers, including but not limited to:

• Diagnostic and Imaging Equipment
• Surgical Instruments
• Implantable Devices
• Orthopedic and Prosthetic Devices
• Dental Devices
• Software as a Medical Device (SaMD)
• IVD (In-Vitro Diagnostic) Devices (EU IVDR 2017/746 support also available)
• Reusable Surgical Instruments
• Sterile and Measuring Devices

Whether you’re a manufacturer based in India or abroad looking to access the EU market, Rico Solutions India Private Limited is equipped to be your regulatory backbone.

Our Proven Process to Achieve EC Certification

We follow a well-structured and transparent process to lead our clients through EC Certification with minimum stress and maximum efficiency:

Step 1: Product Classification & Regulatory Pathway Analysis

We assess your device classification per MDR rules and define the regulatory strategy for compliance.

Step 2: Gap Assessment

We conduct an in-depth assessment of your existing documentation, processes, and QMS to identify compliance gaps.

Step 3: Technical File Compilation

Our team helps build and review your technical documentation for completeness and regulatory adequacy.

Step 4: Clinical Evaluation & Risk Analysis

We compile comprehensive CERs, benefit-risk analyses, and clinical data evaluations in line with MDR standards.

Step 5: QMS Implementation or Upgrade

We ensure your QMS meets MDR and ISO 13485:2016 requirements, helping you prepare for audits.

Step 6: Notified Body Engagement

We identify a suitable notified body, assist with application submissions, and coordinate audit readiness.

Step 7: Certification Support & Audit Handling

We prepare you for the notified body audit and address any non-conformities identified during the process.

Step 8: Post-Certification Services

We provide continuous support for PMS, PSURs, vigilance, and regulatory updates post-EC Certification.

Why Choose Rico Solutions India Pvt. Ltd. for Your MDR Journey?

Expert Regulatory Team

Our consultants include former notified body auditors, clinical researchers, and regulatory professionals with deep domain expertise.

Time-Tested Methodology

We use proven templates, checklists, and systems that streamline MDR implementation and reduce the burden on your internal teams.

Client-Centric Approach

We offer personalized services tailored to your product category, company size, and market goals.

Cost-Effective Solutions

Our India-based operations ensure you receive world-class service at competitive pricing without compromising quality or timelines.

Global Recognition

Our clients span across Europe, Asia, the Middle East, and the United States—testifying to our global experience and trustworthiness.

Client Success Stories

Rico Solutions India Pvt. Ltd. has successfully helped dozens of Indian and international clients achieve MDR compliance. From startups with innovative software-based medical devices to large manufacturers of implantable devices, we’ve played a vital role in securing CE marking and unlocking the European market.

One such case involved assisting a Class III orthopedic implant manufacturer through rigorous technical documentation, biological evaluation reports, and a successful notified body audit—resulting in EC Certification within record time.

Future-Ready Compliance with Rico Solutions

With the European regulatory landscape becoming stricter, MDR and IVDR compliance is no longer optional—it is essential for survival and growth. Rico Solutions India Private Limited is your partner in building a compliance roadmap that is not just reactive but proactive and future-proof.

We also provide MDR transition services for companies shifting from MDD, continuous training workshops for regulatory teams, and regular updates on EU MDR amendments.

Let’s Achieve Compliance Together

EC Certification under EU MDR 2017/745 is a critical milestone, and Rico Solutions India Private Limited is here to help you achieve it with confidence and clarity. Whether you’re launching a new device or updating legacy systems, we guide you every step of the way—from documentation to audits to post-market surveillance.

Partner with Rico Solutions India Pvt. Ltd. today and take your medical device global, secure in the knowledge that you meet the world’s most rigorous regulatory standards.