Our Core Services

1. ISO 13485:2016 QMS for Medical Devices

ISO 13485 is the globally accepted standard for quality management systems specifically for the medical device industry. Rico Solutions India offers end-to-end support in implementing, auditing, and achieving ISO 13485 certification, ensuring your QMS aligns with international regulatory requirements.

Our services include:

• Gap analysis and readiness assessment
• Documentation support and training
• Internal audits and mock inspections
• Liaison with certification bodies for smooth audits

Whether you’re a startup or an established manufacturer, our ISO 13485 consultants ensure your processes meet the highest standards of quality and safety.

2. ISO 9001 (for Medical Devices) with ISO 13485 Integration

For organizations seeking dual certification, we provide specialized guidance on integrating ISO 9001 and ISO 13485 into a unified management system. While ISO 9001 offers a general quality management framework, combining it with ISO 13485 ensures comprehensive regulatory compliance specifically tailored to medical devices.

Benefits include:

• Improved risk management
• Enhanced operational efficiency
• Better global market access
• Simplified audit processes with integrated documentation

Our team ensures that your business derives maximum value and global recognition from these certifications.

3. EC Certification (EU MDR 2017/745)

With the European Union’s Medical Device Regulation (EU MDR) now in full effect, obtaining EC Certification is critical for manufacturers looking to access the EU market. Rico Solutions India provides expert support throughout the EU MDR (2017/745) compliance process.

Our EC Certification services include:

• Classification of medical devices
• Technical documentation development (including Annex II and III)
• Clinical evaluation report preparation
• Risk management files and PMS/PMCF planning
• Notified Body coordination and audit support

Our regulatory experts ensure that your devices meet the stringent requirements of the EU MDR, helping you secure and maintain your CE mark efficiently.

4. UKCA Marking for the UK Market

Post-Brexit, UKCA (UK Conformity Assessed) marking has become mandatory for medical devices sold in the United Kingdom. Rico Solutions India helps manufacturers seamlessly transition or expand into the UK market by providing complete assistance for UKCA certification.

Our UKCA Marking services include:

• Device classification and conformity assessment
• Technical documentation preparation and updates
• Liaison with UK-approved bodies
• Labeling and declaration of conformity support

Our team ensures a smooth and compliant entry into the UK market under the new regulatory landscape.

5. MDSAP Certification (Medical Device Single Audit Program)

MDSAP allows manufacturers to undergo a single regulatory audit to satisfy the requirements of multiple jurisdictions, including the USA, Canada, Japan, Australia, and Brazil.

Our MDSAP services include:

• Gap analysis of QMS for MDSAP readiness
• Multi-jurisdictional audit preparation
• Documentation updates in line with regulatory expectations
• Audit simulation and corrective action planning

Rico Solutions India helps you leverage MDSAP to reduce duplication, lower costs, and enhance global compliance.

6. 510(k) Clearance Support (FDA – USA)

Selling a medical device in the US market often requires a 510(k) premarket notification to the FDA. Rico Solutions India offers specialized advisory and support services for preparing and submitting 510(k) applications.

We assist in:

• Determining regulatory pathway and predicate devices
• Building comprehensive 510(k) dossiers
• Test data validation and review
• Communication with FDA and follow-up assistance
• Factory audit preparation and compliance checks

With our proven expertise, we help clients accelerate their 510(k) clearance process while ensuring full technical and legal compliance.

7. PMA Submission (Premarket Approval for Class III Devices)

For high-risk Class III devices that require PMA (Premarket Approval) from the FDA, Rico Solutions India provides extensive regulatory strategy and submission support.

Our PMA services include:

• Device classification and clinical data assessment
• Compilation of investigational device exemption (IDE) data
• Assistance in clinical trials and risk-benefit analysis
• Preparation of PMA modules and full dossier
• Post-submission follow-up and FDA engagement

We help you navigate the most rigorous FDA pathways with confidence, ensuring clinical safety and data integrity are maintained throughout.

Why Choose Rico Solutions India?

Comprehensive Service Portfolio

From ISO certifications to complex international regulatory approvals, we cover the entire lifecycle of medical device compliance.

Experienced Regulatory Experts

Our team comprises certified auditors, regulatory consultants, and quality specialists with in-depth knowledge of global standards and frameworks.

Global Market Access

We simplify the path to markets across Europe, the UK, the USA, Canada, Australia, and more, enabling our clients to expand internationally.

Tailored Solutions

Each organization is unique, and so are our solutions. We provide customized regulatory strategies based on your device classification, market targets, and internal capabilities.

Proven Track Record

We have helped numerous startups, SMEs, and large corporations achieve successful certifications and registrations within budget and time constraints.

Industries We Serve

• Medical device manufacturers
• Diagnostic device producers
• Dental and surgical equipment providers
• Wearable health tech firms
• OEM suppliers in healthcare
• Hospitals and clinical labs with in-house device production

Our Process

1. Initial Consultation and Assessment
   We understand your needs, products, and regulatory goals to draft a clear roadmap.
2. Documentation and System Development
   Our experts help build or refine your QMS, technical files, and submissions.
3. Training and Audit Readiness
   We prepare your team for internal, external, and regulatory audits.
4. Certification and Regulatory Approvals
   We coordinate with certification bodies and regulators for smooth approvals.
5. Ongoing Compliance and Maintenance
   Our post-certification services ensure continuous compliance and support during surveillance audits or product upgrades.

Partner with Confidence

In the fast-evolving medical device landscape, regulatory hurdles can slow down innovation and market access. Rico Solutions India Private Limited is your reliable bridge to international success, providing expert-led certification and advisory services that empower your organization to focus on what you do best—developing life-saving medical technologies.

Get in touch with Rico Solutions India today and take the next step toward regulatory excellence and global recognition for your medical devices.