Mediteq offers this service for you who want to obtain basic information on what is required to get your product, product idea, or concept approved for use.
A regulatory analysis provides answers to the following questions:
- Is it a medical device?
- Classification within the EU and the US
- Types of product approvals required in the EU and the US
- Documentation needed to obtain product approval
- Requirements for management systems
The regulatory analysis is delivered in the form of a report presented at a meeting.
Mediteq offers expert advice to develop the strategy to get your medical device approved and ready for distribution and use in one or more markets. Typically, the EU and the US are covered as primary markets, but other countries can also be included.
A regulatory strategy includes:
- Requirements for market access in each market
- Documentation required for the product
- Clinical data – Are existing data sufficient, or is a study needed?
- Standards to be met, and the need for testing at testing facilities
- Applications required for each country or market
- Timeline and fees for each application
- Registration requirements – actor and product
- Requirements for management systems and audits
- Is independent review by an NB or authority required? Possible NBs to use within the EU.
A regulatory strategy is based on:
- A business plan for the product with specified countries
- Product classification for each market, e.g from a regulatory analysis
The regulatory strategy is developed during joint meetings and is delivered in the form of a written report.
Internal audit is a service evaluating how well your organization follow your own established procedures, quality management system standards such as ISO 9001, ISO 13485 and regulatory requirements like MDR/IVDR in Europe and QSR in the US. An audit is an on-site visit to independently review your work processes and documentation.
Mediteq can perform internal audits of the complet or part of your business, such as control of suppliers or subcontractors or design control. As a customer, you decide the scope of the audit, both the timeline and parts of the management system to be audited.
Mediteq performs document reviews, interviews, site visits, and sample checks to audit the business and compare the results with defined audit criteria. We focus on finding improvements to provide value in your future work.
Quality and management responsibility are often included in the audit scope to assure the independency.
Internal audits can be used:
- When you have developed a management system on your own and want to know if the system meets the requirements
- When you lack your own internal auditors
- When there are problems with independence, such as quality management and management responsibility
- For specific problem areas in your operation
- Before external audits or inspections e.g from notified body or authorities like FDA or Läkemedelsverket
- Train personnel to be audited
Mediteq can help you to find out how well your products and operations complies with the regulatory requirements of MDR or IVDR. This service suites companies that have manufactured medical devices for a long time according to previous directive, but also younger companies with new products. Mediteq will deliver a clear picture of your compliance to the regulatory requirements.
- Technical documentation for one product or product group
- Management system – procedures and processes
- Digital or on-site at your request
A GAP analysis provides answers to the following questions:
- What changes affect your operation and your products?
- Reclassification according to the new regulations – is it necessary?
- What is missing from your technical documentation?
- What needs to be updated or changed to meet the requirements?
- Management system – Does it cover all the required parts?