Our services

Regulatory Compliance

We guide you through the entire regulatory lifecycle from early classification to global approvals.

Quality Assurance (QMS)

Build robust, audit-ready Quality Management Systems aligned with ISO 13485 and regional standards.

Research and Development Services

We ensure your innovation aligns with regulatory expectations from day one.

Preclinical Testing Support

Scientific support and coordination for ISO-compliant testing.

Training & Capacity Building

Upskill your team and ecosystem with regulatory and quality training tailored for real-world challenges.

Packaging & Labeling

We manage the critical details to ensure your product is shelf-ready and globally acceptable.

Digital Solutions for MedTech

We create powerful digital assets that communicate, train, and streamline your compliance journey.

Clinical Evalution

Clinical evaluation ensuring medical device compliance and safety

Sterlization

Sterilization validation ensuring device safety and compliance.

Supply Chain

Streamlined supply chain solutions for medical device compliance.

Sustainability

Sustainable practices for compliant and eco-friendly medical devices.

Our Process

Simple. Strategic. Scalable.

we follow a proven, streamlined process to get your innovation from idea to market — with full compliance.

1

Discovery & Strategy

We start with a free consultation to understand your product, goals, and compliance needs. Then we chart a custom roadmap aligned with regulatory milestones.

2

Documentation & Planning

We help you build or align technical files, QMS systems, and product risk assessments — all tailored to your region and device type.

3

Implementation

From training to eQMS setup, clinical evaluations to testing coordination — we execute your compliance framework step by step, with full support.

4

Submission & Approvals

We prepare and manage regulatory submissions, including interactions with CDSCO, CE bodies, FDA, or other authorities — ensuring timely, audit-ready results.

5

Post-Market Support

Once approved, we help you stay compliant — with surveillance, labeling updates, vigilance systems, and global scale-up planning.

Simple

Strategic

Scalable