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Consulting
Mediteq has a service for those who need to bounce ideas with an expert, who can assure that you get answers to all your questions regarding legal requirements, regulations and standards for medical technology and diagnostics. We can deliver immediate answers or help you find answers and additional information, no matter what your question is.
Our expertise covers all areas of medical technology, from evidence strategy and regulatory plan, to review by Notified Body (NB) or authority. And also technical documentation for complex products with high patient risk, and management systems for the sole proprietorship and the international enterprise.
Questions we face in counseling:
- 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 it the GDPR or the Patient Data Act that is applicable?
With us, you can sign an advisory agreement in advance, so that you have access to an expert when the questions or challenges arise.
Contact us for advice!
Operational management
Do you need consulting in regards to regulatory requirements and quality for medical technology or diagnostics? Are you in need of someone who can help write and compile reports, product registrations or update parts of your management system? Then you need an operational manager to get the job done on time, even if you currently don’t have enough 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 used to working according to routines in management systems.
Tasks within operational management:
- Complaint or deviation handling
- Compile, update and implement product registrations
- Update of routines and documents in management systems
- Collection and compilation of aftermarket data
- Update and review of risk documents
- Literature searches for clinical or biological evaluation
Operational processing can be signed for a certain ‘working time’ over a longer period of time, or for a specific work task, for example a product registration.
Contact us for help with the daily work in the regulatory or quality department!
PRRC – Person Responsible for Regulatory Compliance
Mediteq has a service for those 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:
- Regulations, MDR or IVDR
- The number of products and generic product families
- Management system – certified or not, follows ISO 13485 or ISO 9001
- The size and competence of the organization
In order for Mediteq to perform this service, we need to qualify, i.e. check your company and your products in advance by reviewing technical documentation and auditing your management system.
The PRRC is responsible for ensuring that there is 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.