At Mediteq, you get access to an expert
or extra staff to handle
questions or challenges
Mediteq has experts with whom you can discuss all your ideas and assure that you get answers to all your regulatory questions about standards, regulations, approvals and registrations for medical devices and diagnostics. We answer or help you to sort out the details and get additional information, no matter what your question is.
Our expertise covers all areas of medical technology, from evidence strategy and regulatory plans, to review by Notified Body (NB) or authority. And also technical documentation for complex products with high patient risk, and management systems for start-ups and international enterprises.
Questions we get:
- Is this a medical device or an in-vitro diagnostic product?
- What is needed to get it CE-marked or approved by the FDA?
- What approvals are required in the EU or the US?
- Management system – Is it a requirement? Does it have to be certified?
- Clinical trial – Is it necessary?
- How much clinical data is needed for my product?
- Risk management – How is it done? And can it be simplified?
- Data management – Is GDPR or another regulation applicable?
Do you need support in regulatory and quality area for medical devices, software or in-vitro diagnostics? Would you like someone who can help write and compile reports, product registrations or update parts of the management system? When you contract operational services from Mediteq, the job will be done on time, even during periods of limited staff.
Mediteq’s consultants have experience in various tasks within the quality and regulatory area, such as searching and compiling data in an efficient and clear way, or quickly writing texts and reports in English or Swedish. Mediteq’s consultants are efficient with new tasks, organizations and products and are trained to work according to routines in management systems.
Tasks within operational services:
- Complaint or deviation management
- Compile, submit and maintain product registrations
- Update routines and documents in the management systems
- Collection and compilation of postmarket data
- Update and review of risk management process and files
- Literature search for clinical or biological evaluation
Operational services can be contracted with different scope, e.g half time, over a longer period of time, or for a specific work task, e.g product registration.
PRRC – Person Responsible for Regulatory Compliance
Mediteq has a service for you who want help with skills and resources for this position of responsibility. The service is for manufacturers and authorized representatives of medical devices that qualify as small businesses or micro-enterprises according to the EU definition, i.e. less than 50 employees.
Varying factors for PRRC service:
- Regulations – MDR or IVDR
- The number of products and product families
- Management system – certified or not, ISO 13485 or ISO 9001
- The size and competence of the organization
In order for Mediteq to perform this service, we need to qualify company and your products in advance by reviewing technical documentation and auditing your management system.
The PRRC is responsible for ensuring correct and complete technical documentation (according to the MDR or IVDR) for all your medical devices and a sufficiently comprehensive management system that works for all the activities required according to the MDR or IVDR.