confinis – regulatory compliance worldwide
confinis is a global regulatory affairs and quality management consulting firm specializing in medical devices, Combination Products, and in-vitro diagnostics. Established in Switzerland in 2005, confinis operates out of both Switzerland and the United States for customers worldwide.
Our name is analogous to our business model
confinis is derived from Latin and translates to, among other things, adjacent, adjoining, the missing particle.
We want to fill the place of the missing particle in your business and attain success together.
Our fields of expertise
Looking for efficient and effective advice regarding medical devices, combination products, and in-vitro diagnostics? confinis scale in its services to you, is getting it right the first time!
confinis services include
Take advantage of confinis’ globally unique level of experience and be among the world’s leading pharma, biotech and biosimilar companies we are proud to be working with. It does not matter whether the combination products are prefilled syringes with or without a needle safety
system, auto-injectors, pen-injectors, inhalers, stents or drug-eluting patches.
Your scope for your product is global? So is our expertise, when it comes to delivering a sound Regulatory Strategy or submission documentation for your market access. Let us know where you want to see your product sold and we take care of compiling the required paper work and dealing with the approving authorities obtaining the required Market Authorization.
The effectiveness and efficiency of your design control procedures are key to create value throughout product development. We are ready to assist your teams in its creation, including an ISO 14971 compliant risk management process and if applicable software life cycle processes according to IEC 62304. Furthermore, we support your project teams in writing documents for the Design History File and regulatory submissions.
Demonstrate the safety and effectiveness of your device not only as part of the product validation but throughout the product life cycle by sound clinical evaluation and post-market clinical follow-up activities. Our senior subject matter experts assist you in securing the availability of clinical data and reports demonstrating compliance with MEDDEV 2.7/1 Rev. 4 and EU MDR 2017/745 requirements.
Build and maintain your engine in operations. One of confinis’ core competence is the establishment and maintenance of quality management systems that meet the requirements of ISO 13485, the US regulations and the other MDSAP members. Consider confinis for the execution of your internal audits, mock inspection and supplier audits to identify areas of potential for improvement.
Once your product is on the market, secure your pro-active and reactive surveillance activities are working hand-in-hand and relevant findings are considered in your vigilance, risk management and design control processes. The confinis team has experience in various organizational set-ups to support you in defining and implementing sound processes that are workable for you. Additionally, we are ready to contribute hands-on in day-to-day execution of those processes as well as in aspects like monitoring of authority databases regarding safety-related reports about competitor and comparable products, analysis of relevant literature and registers and regular revision of your clinical evaluations.
The knowledge about the classification of your app in the markets you are interested in will have an impact on development, testing and documentation requirements.
Devices composed of substances
You want to make sure to understand if your product needs to comply with EU MDR 2017/745, Annex VIII, Chapter 3, Rule 21 and if not which other regulation applies. For assistance determining pertinent regulatory and normative requirements for your products.
Person responsible for regulatory compliance
EU MDR 2017/745 and EU IVDR 2017/746 demand for a “person responsible for regulatory compliance”, which in small organizations can be managed by assigning a confinis consultant.
US agent services
We can represent you towards FDA, if you do not have a presence in the US yourself, but you want to sell or have your products sold in this market.
Executing internal audits, supplier audits, and mock-inspections with the support of our qualified experts, secures your compliance with ISO 13485 and US regulatory requirements, and helps to identify potential for improvement.