Medical Device Development Company in India

Introduction to Medical Device Development at Criador Labs

At Criador Labs, our goal is to be at the forefront of MedTech innovation and regulatory precision. We have worked with start-ups and mid-sized firms, as well as enterprise clients, through each stage of the healthcare development lifecycle. As a medical device development company in India, we guide projects from the first sketch until final production.

How We Work

Beginning with ideation and design, to creating prototypes, ensuring regulatory compliance, and production handoff, we have helped businesses meet their needs with our products and expertise. We’ve worked with teams from day one by shaping ideas, building prototypes, handling compliance, and supporting their first production runs.

Our Track Record

With over 100 successfully executed projects across India and the US, we specialise in high-complexity domains and regulated markets. As a healthcare product development company, we prioritise ISO 13485 compliance to deliver products that align with global standards like the FDA (US) and CDSCO (India).

Regulatory Classes We Work With

We understand that regulatory compliance is critical for medical devices, which is why we work tirelessly to ensure our products work seamlessly across India’s CDSCO and US FDA frameworks.

1. Navigating US FDA Regulations

We design and manufacture devices that fall under the following categories:
Class I – These are medical devices that are considered low risk and are therefore subject to fewer checks

Class II – These are medical devices that are considered to be of moderate to high risk for patients or users. They usually have additional special controls, along with general controls, to ensure product safety and effectiveness.

Class III – These are extremely high-risk medical devices that are subject to stringent regulatory checks due to their potential to cause severe harm or, even be life-threatening in some cases.

This includes everything from oxygen masks to surgical instruments, infusion pumps, ECG monitors, and implantable systems.

Our support extends to managing risk in line with ISO 14971, preparing DHFs (Design History Files), and compiling PMA submissions or FDA 510(k).

2. Meeting CDSCO Standards in India

We engineer devices that are adherent to CDSCO Class A (where A signifies low risk while D signifies high risk) to Class D categories. Our support extends to the preparation of TF (Technical Files), DMF (Device Master Files), and CER (Clinical Evaluation Reports). We also guide our clients in the licensing process using Forms MD-14, MD-15, and MD-23/24. As a certified medical device design firm, we build every product with compliance at its core.

Medical Specialties We Cover As a Medical Device Development Company in India

We have successfully delivered across multiple medical disciplines, each needing specific regulatory precision and technological fluency.

ENT (Otolaryngology): We have developed audiology aids, diagnostic scopes, and wireless endoscopes that deliver real-time assessments.
Ophthalmology: We have developed diagnostic lenses and portable retinal imaging systems that function effectively in both remote and clinical settings.
Cardiology: We specialise in heart rate monitors and wearable ECG patches that can securely and continuously track patient data.
Pulmonology: We have designed oxygen saturation monitors and smart spirometers that deliver clinical-grade data in hospital or home settings.
Neurology: We have worked on EMG sensors and neurostimulation wearables that can track neural pathways.
General Surgery: We have engineered diagnostic tools and electrosurgical units that provide high accuracy and reliable safety in high-pressure environments.
Gynaecology and Neonatal Care: We have designed neonatal thermoregulation systems and monitoring devices.
Rehabilitation: We have built mobility aids and posture monitors that are widely used as rehabilitation applications.

Technology Expertise

We have built a world-class team that is capable of meeting medical technology’s interdisciplinary demands.

1. Wireless and Embedded Systems

Our wireless systems are powered with seamless data transmission through Wi-Fi, BLE (Bluetooth Low Energy), and Zigbee. Our embedded firmware is designed with real-time OS capabilities and power optimisation, which is essential for wearable or mobile devices.

2. Sensor and Cloud Integration

Our team specialises in the integration of sensors such as PPG, ECG, motion, temperature, and SPO2 within power-efficient and compact hardware. We follow HIPAA rules across all apps and cloud setups. Patient records stay protected on every platform.

3. Prototyping and Testing

Our hardware is built for clinical use and includes compact forms, easy handling, and a reliable fit in care settings. As a product designing company, we use SLA/SLS 3D printing to develop fast, testable prototypes. Bench tests are conducted in-house for early validation. Whether it’s a wearable patch or a clinical diagnostic tool, we validate form and function before anything goes to scale.

4. Standards and Certification Prep

Our devices are IEC 60601 and IEC 61010 compliant, ensuring that electromagnetic interference and safety requirements are emphatically addressed.

Criador’s Medical Device Development Process

1. Step-by-Step Approach

We employ a modular development process that prioritises structure and compliance. Our process begins with risk analysis and discovery. This is essential to align user needs with significant regulatory and safety challenges.

2. Design Input to Engineering

Once the design input is finalised, we proceed towards translating this to executable design requirements. At this stage, our multidisciplinary engineering and industrial design teams proceed with electrical, mechanical, and embedded development while ensuring design cohesion.

3. Prototyping and Verification

At the next stage, we move on to rapid prototyping and bench testing. This is done using visual and functional models to validate initial assumptions quickly. At the verification stage, we confirm that all design outputs meet the inputs through structured testing.

4. Documentation and Handoff

We provide complete regulatory documentation packages for FDA, CDSCO, or CE submissions. We also provide support for pilot production runs with supplier selection, DMR handoff, and quality control advisories. At every stage, our process aligns with ISO 13485:2016, FDA QSR, and EU MDR best practices.

Why Choose Criador Labs for Medical Device Development?

Our process is not just predicated on technical specialisation. With us, you get hands-on product intuition, regulatory depth, and systems thinking. We place regulatory compliance at the forefront of our design process, instead of thinking about it as an afterthought. By working with us, your business can benefit from the expertise of industry-leading embedded engineers, product designers, and regulatory experts.

Let’s Build What’s Next in MedTech

We are not just in the business of building devices; as a trusted medical design company, we want to play a vital role in shaping healthcare futures. If you want to collaborate with a design partner that’s an expert in embedded design, regulatory intricacies, and industry-grade usability, then you have landed at the right place. Let’s talk about what’s next in diagnostics, wearables, or therapeutic systems.

FAQs For Medical Device Development in India

What is ISO 13485, and why is it important in medical device design?

ISO 13485:2016 is a global quality management standard for medical devices. It ensures design processes meet safety, performance, and regulatory standards like the FDA and the CDSCO. Criador is certified under ISO 13485.

Does Criador Labs offer FDA documentation support?

Yes. Criador supports the creation of Design History Files (DHF), Risk Management Files (RMF), and FDA 510(k) or PMA submission documents as required for regulatory clearance.

Can Criador help with CDSCO registration in India?

Yes. We assist with CDSCO registration, including Device Master File (DMF), Technical File (TF), Clinical Evaluation Reports (CER), and guidance on Forms MD-14/15 and MD-23/24 for importers and manufacturers.