Regulatory
strategy
Why Strategy?
Considering regulatory requirements is very important for any company who intends to design, develop and sell a medical device.
When a new device is being designed, the regulatory strategy should be created in the early phase of the design and development process.
The complexity of regulatory requirements, timelines for regulatory clearances and approvals, availability of regulators and the regulatory-related cost must be always kept in mind when creating a marketing strategy for a device.
Meliora Compliance will help you to prepare a regulatory strategy for your device, while taking into consideration the following aspects:
- Determination if your product is a medical device or not
- Future ownership of regulatory approvals (who will be the manufacturer)
- Involvement of other economic operators (distributors authorized representatives, importers)
- Current regulatory status (already on the market in some territories?)
- Target markets and their prioritization (EU, US, both, other countries)
- Desired market launch dates
- Complexity of regulatory requirements in the target markets
- Intended use of your device
- Device classification
- Current phase of your device lifecycle
- Availability and qualification of regulatory resources needed
- Regulatory cost, both internal and of third parties
- Clinical evidence available and planned
- Equivalence to other devices already marketed
- Status of quality management system
- The ability to perform post-market surveillance activities
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