Every modern treatment, whether a life-saving medical device or a cutting-edge therapy, goes through a long journey of testing before it can reach patients. This process, known as clinical research, ensures safety, quality, and trust. Today, as the medical device industry in India rapidly expands, trained professionals in clinical trials and regulatory support are in high demand. But what does it take to build a career in this field?
Step 1: Understand What the Industry Needs
Clinical trials for medical devices differ from drug trials — they focus on performance, safety, and how the device interacts with users. This means companies look for people who understand:
- clinical data analysis
- safety evaluation
- human factors engineering
- regulatory compliance
According to industry professionals like Manisha Chauhan, an alumna of Apeejay Stya University currently working in MedTech, “Students should mainly focus on regulatory knowledge and clinical research phases.”
These skills form the bridge between innovation and patient care.
Step 2: Choose the Right Specialisation
For science graduates, a post-graduate degree such as MSc in Clinical Research is one of the most direct and valuable pathways into the field. Key components taught in these programmes — including Biostatistics, Medical Writing, Clinical Data Management, and Quality Assurance — are exactly what companies expect fresh talent to know.
This education ensures students can contribute to real-world R&D and device evaluations right from the start.
Step 3: Learn Quality & Regulatory Standards
Medical devices must meet strict regulations before approval for use in hospitals. Platforms follow international frameworks like ISO 13485 and Quality Management Systems (QMS).
As Manisha shares, “Here, quality is managed by assuring ISO 13485 standards and maintaining QMS as per standards.”
Understanding these protocols gives candidates a major competitive advantage in the job market.
Step 4: Gain Industry Exposure Early
Internships and practical projects are crucial to building confidence and employability. Working alongside researchers and QA teams helps students learn:
- how device documentation works
- how clinical trial data is recorded
- how global approvals are secured