Our services will help your company acquire CE-markings and official approvals easier all over the world. We have special expertise in registering demanding implantable devices and surgical instruments. We will tailor our service according to your objectives, whether you need one missing piece of your process or the whole package.
Your company will save resources, while we handle every stage of applying for CE-markings.
Does your company manufacture medical devices outside of the EU? We serve as an authorized representative in Europe.
Medical device manufacturers must have a sales approval from the FDA (Food and Drug Administration) in the United States.
We will help your company plan a quality management system and write your quality manual.
We will plan your quality management system and write a quality manual in accordance with the ISO 13485, ISO 9001, US FDA QSR, and CMDCAS standards. The result of our work will be a certified quality management system that also takes into consideration the special requirements of the directives and laws.
We perform product registrations for our customers globally. Our head office is in Tampere. All of our experts working around Finland have over 10 years of experience in medical device registration, quality systems and product development. All together, we have done hundreds of registrations.
I am responsible for medical device registration strategies, sales approval applications in Europe and the United States, and product development documentation. I have a M.Sc. degree in Materials Engineering, and I wrote my doctoral thesis on implantable materials.
I have over 15 years of experience in developing and registering medical devices. I also have work experience from management positions in research and product development in Finland and the United States. I have special expertise in strategies for the approval and testing of implants.
I am a specialist in sales approvals and registrations of medical devices. I have over 15 years of experience in the field. My duties and responsibilities as a Quality and Regulatory Affairs Manager include, for example, creating medical device registration strategies globally, preparing sales approval applications for various market areas, renewing and maintaining existing approvals as well as following the constantly changing regulations for medical devices.
I’m also responsible for creating and improving quality management systems from the beginning to the phase, where quality systems can be certified. I have worked as a Quality Manager and QA management representative. In addition, I’m a qualified lead auditor and can act as an internal auditor and a supplier auditor. I have also performed internal trainings for our customers and been the responsible person for authorized EC representative.
I am a medical device professional with 10+ years experience in surgical implant and instrument development and a M.Sc. degree in materials engineering.
As a product development specialist, I have responsibility for product development project management and documentation according to ISO 13485 quality management system standard. This includes, for example, project design control, risk management, verification and validation activities and ensuring product's quality and regulatory compliance. I also have experience in quality management system development.
I am a specialist in planning instruments and implants. I have over 25 years of experience as a user and designer of medical devices. By my training I am a surgical specialist. My strength in designing devices is in the manufacturability and usability aspects of the devices. I have experience in designing hundreds of instruments and implants. In addition, I help our customers in commercializing medical devices.
Do you have a whole bagful of product ideas? Are you developing a device? Are there deficiencies in your quality management system? Do you need a sales approval? Read about our customers’ situations where we have taken responsibility for applying for their approvals from the authorities and offered our expertise for their product development.
Our customer had a CE-marking for a medical device that they also wanted to sell in the United States.
A start-up company had a product under development, but no quality management system. We made a plan, a budget and an outline for a quality manual.
Our customer wanted a CE-marking for an implant in the highest-risk class. We made a registration plan that included countries outside of Europe for possible future needs. The customer had written preliminary documents.
A start-up company had an idea for a product that would consist of several product generations. It was an active implantable medical device. Together with our customer, we made a global regulatory roadmap for the consecutive product generations and their launching schedules.
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