A regulatory strategy is basically a formal plan that aligns regulatory activities to your business strategy. While planning your regulatory strategy you should consider various issues within your target markets. A regulatory strategy should support your company’s mission and vision, be achievable, balanced, and realistic.
How we can help you
- Develop bespoke Quality Management Systems based on ISO 13485
- Prepare your Technical File / Dossier (CE mark, FDA)
- Medical device hazard analysis and risk management
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