Planning and developing your strategy
Developing a robust regulatory strategy and aligning it to your business is key to success. A regulatory strategy includes information such as:
Business activities and targets/goals set by the management,
Medical device description, technology and intended use,
Key target markets for commercialisation,
Medical device classification,
Regulatory requirements and standards to comply, and
Overall project milestones and timeline.
A good regulatory strategy should evolve accordingly to changes in market needs and regulatory landscape. At Stendard, we work closely with your management and team to achieve this together.