FIENG Services Company Projects Contact Top Expert in Medical Device Registrations Worldwide. CE-Markings and Official Approvals Globally. The Agile Path toward Sales Approvals 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. CE-Marking Your company will save resources, while we handle every stage of applying for CE-markings. READ MORE↓ Authorized EC Representative Does your company manufacture medical devices outside of the EU? We serve as an authorized representative in Europe. READ MORE↓ Sales Approvals in the USA Medical device manufacturers must have a sales approval from the FDA (Food and Drug Administration) in the United States. READ MORE↓ Quality Management Systems We will help your company plan a quality management system and write your quality manual. READ MORE↓ Mectalent Medical Services Oy 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. JUHA-PEKKA NUUTINEN PÄIVI MESIRANTA LEENA RAUNIO TERHI HEIKKINEN OLLI KARHI Juha-Pekka Nuutinen SPECIALIST – REGULATORY AFFAIRS, CHAIRMAN OF THE BOARD In addition to the duties of General Manager, 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. LINKEDIN jp.nuutinen From Product Ideas toward Sales Approvals 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. The FDA 510(k) Application Our customer had a CE-marking for a medical device that they also wanted to sell in the United States. We made a registration plan for the FDA 510(k) application, stating the device’s classification, the approval process, and issues necessary for registering the company in the United States. We made the application for our customer, including all necessary appendices. During the project, we noted that design validation and verification, as well as product risk management should be improved. We sent the application on both paper and in electronic form to the authority specified by our customer. THE FDA 510(K) APPLICATION QUALITY SYSTEMS FROM SCRATCH CE-MARKING, CLASS III GLOBAL SALES APPROVAL PLAN < > MECTALENT MEDICAL SERVICES OY Veistämötie 15, 90620 Oulu, Finland Juha-Pekka Nuutinen SPECIALIST – REGULATORY AFFAIRS, CHAIRMAN OF THE BOARD TAMPERE +358 40 8283 210 Olli Karhi GENERAL MANAGER OULU +358 400 684 117 INFO@MECTALENTMEDICALSERVICES.FI Email addresses: firstname.lastname@mectalent.fi Business Id 2538577-9 Unable to display map: google is not defined Our primary billing address is: Nimi Mectalent Medical Services Oy Business Id 2538577-9 E-invoice operator (broker’s ID) 003714377140 EDI ID 003725385779 Broker Enfo Zender Oy If you are unable to send electronic invoices, kindly send a paper invoice to the address: Mectalent Medical Services Oy PL 5042 70701 Kuopio Our postal address is: Mectalent Medical Services Oy Veistämötie 15 90620 Oulu