Top Expert in Medical Device Registrations Worldwide.

CE-Markings and Official Approvals Globally.

The Agile Path toward Sales Approvals

  • eu
  • EU
  • Notified Body & Local Competent Authorities
  • us
  • USA
  • FDA/Food and Drug Administration
  • ca
  • Canada
  • Health Canada
  • au
  • Australia
  • TGA/Therapeutic Goods Administration
  • tu
  • Turkey
  • Ministry of Health
  • sk
  • South Korea
  • MFDS / Ministry of Food and Drug Safety (previously KFDA/ Korea Food and Drug Administration)
  • ta
  • Taiwan
  • TFDA / Taiwan Food and Drug Administration
  • bz
  • Brazil
  • ANVISA / Brazilian National Health Surveillance Agency
  • si
  • Singapore
  • HAS / Health Sciences Authority
  • ch
  • China
  • CFDA/China Food and Drug Administration

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.

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Applying for a CE-marking is a demanding and often laborious puzzle that can take, even at its best, several weeks in this highly regulated field. We will make sure that your product and application meet the strict requirements, making it easier and quicker for your company to get a sales approval in the European economic region.
  • We will help you draft and write the documents so that they meet all the requirements.
  • We will make sure the contents of the documents are consistent.
  • Based on the documents, we will make a CE-marking application in clear writing.
  • We will compile the technical documentation (technical file / design dossier).
  • We will take care of all the communication with the Notified Bodies.
The CE-marking is the manufacturer’s declaration that the product meets the essential requirements of the EU. The requirements of medical devices are stated in three EU directives. In addition, for example, France, Italy, Spain and Portugal have additional requirements for registering medical devices.

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Authorized EC Representative

Does your company manufacture medical devices outside of the EU? We serve as an authorized representative in Europe.

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If you want a sales approval for a medical device in Europe, the directive requires an authorized EC representative. We serve as an authorized EC representative for medical device manufacturers outside of the EU who need a registration and sales approval in the EU.
  • We take care of registering the medical device with local authorities and make separate, country-specific applications when necessary.
  • We serve as a contact between the manufacturer and the EU authorities.

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Sales Approvals in the USA

Medical device manufacturers must have a sales approval from the FDA (Food and Drug Administration) in the United States.

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The approval application procedure in the United States depends on the device’s classification. At its easiest, it can be a mere device listing, a 510 (k) application for most class II products, or a PreMarket Approval procedure for devices of the highest risk class.
  • We will find out what kind of application procedure and documents your device requires in the United States, and we will plan a strategy for you.
  • We will help you make the necessary documents and to revise your existing documents to meet the US standards.
  • We will write your application and serve as a contact between you and the FDA.

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Quality Management Systems

We will help your company plan a quality management system and write your quality manual.

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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 will plan your new systems and a quality manual.
  • We will formulate the processes together with the manufacturer of the medical device.
  • We will audit your existing systems and prepare for possible amendments to standards and regulations.

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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

    Specialist – Regulatory Affairs, Chairman of the Board

    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.

    jp.nuutinen

    Päivi Mesiranta

    Regulatory Affairs Manager & Qualified Lead Auditor

    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 Regulatory Affairs Manager include, for example, creating medical device registration plans globally, making sales approval applications for various market areas, and renewing and maintaining existing approvals.

    I’m also responsible for writing and improving quality system processes as well as certifying quality management systems for our customers. 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. 

    p_mesiranta

    Terhi Heikkinen

    Product Development Specialist

    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.

    terhi.j.heikkinen

    Olli Karhi

    General Manager

    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.

    ollikarhi

    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.

    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

    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

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