How to start a service specializing in writing highly technical medical device manuals?

This is a highly specialized and well-compensated niche. Your service isn't just about technical writing; it's about regulatory compliance assurance.### 💼 Establishing Expertise and Compliance:1. Deep Regulatory Mastery: The foundation of this business is knowing the regulations inside out. You must be an expert in India's CDSCO (Central Drugs Standard Control Organization) rules, as well as international standards like the EU's Medical Device Regulation (MDR) and ISO 13485 (Quality Management System). This knowledge is your core product.2. Target Documents: Don't just focus on user manuals. The biggest need is for high-stakes regulatory documents: * Clinical Evaluation Reports (CERs) * Post-Market Clinical Follow-up (PMCF) Plans & Reports * Device Master Files (DMFs)3. Client Acquisition: Target small to mid-sized Indian medical device manufacturers and importers (who require CDSCO registration for sales) and Contract Research Organizations (CROs). Your pitch: "We ensure your device documentation meets global standards, accelerating your regulatory approvals."4. Skill Development: Invest in specific training. Since the regulatory landscape is global, obtaining certification or taking courses focused on [Medical Writing for Medical Devices] (https://ipi.academy/product/details/2469/medical-writing-for-medical-devices) will immediately establish your credibility and technical competence.