The Agile Path towards 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.
Your company will save resources, while we handle every stage of applying for CE-markings.
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.
Does your company manufacture medical devices outside of the EU? We serve as an authorized representative in Europe.
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.
Medical device manufacturers must have a sales approval from the FDA (Food and Drug Administration) in the United States.
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.
We have made registrations eg. to the following countries:
United States, China, Canada, Mexico, Australia, Taiwan, South-Korea, Brazil, South-Africa, India, Saudi-Arabia, Malaysia, Singapore, Japan, Iran, Sudan, Tanzania, Israel, Ukraine, Uzbekistan, Vietnam, Philippines, Argentina, Colombia, Thailand, Chile, Egypt, Costa Rica, Ecuador, Iraq, Peru, Turkey, Indonesia, Syria and Russia
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 20387, 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.
Clinical evaluation of medical device is a multistage and closely regulated process. A carefully carried out process will not only fulfill assessment requirements set by the authorities, but furthermore give manufacturer valuable information of the device’s performance and properties. We are specialized in directives, guidelines, laws and their requirements concerning medical devices, IVD-devices, actively implantable devices, equipment and software.
Mectalent Medical Services’ engineers cooperate with the physicians from COR Group Oy. This allows our customers to use a network of clinical experts to carry out clinical evaluations in an efficient way. Cooperation of Mectalent Medical Service and COR Group offers clinical experts inter alia for following specialties: orthopedics and traumatology, ophthalmology, otorhinolaryngology, skull and face surgery, neurosurgery, urology, neurology, and vascular surgery. In addition, we can offer clinical performance evaluation services for example in vitro diagnostic (IVD) devices.
European commission has published new guideline for medical device manufacturers concerning clinical evaluation procedure (MEDDEV 2.7/1 rev 4). Mectalent Medical Services offers help with clinical evaluation research planning, material collection, analyzing and reporting.
Trainings, Audits, Verifications, Validations, Statistics
Services and industries:
- Medical devices – IVD devices – laboratories
- Device registrations – Trainings – QM-systems – Audits – Statistics – Verifications – Validations – Clinical evaluations
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.
Specialist – Regulatory Affairs, General manager
Certified ISO 13485:2016 Lead Auditor, RAC
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 20 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.
Quality and Regulatory Affairs Manager
Certified ISO 13485:2016 Lead Auditor, FINAS Technical expert, RAC
I am a professional in sales approvals and regulations of medical devices with over 20 years of experience. My duties and responsibilities as a Quality and Regulatory Affairs Manager include, for example, creating medical device and IVD 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 and IVD devices.
Addition to my sales approvals related duties, I build quality management systems according to standards EN ISO 13485, EN ISO 15189 or FDA 21 CFR Part 820 (QSR) either from the beginning when I also help to select the Notified Body for my customer (EU) or, if required, I also improve and update already existing quality management systems.
In my work as a Quality and Regulatory Affairs Manager I have acted as a management representative as required by the standard and nowadays also as a regulatory compliance person as required by article 15 in the Medical Device Regulation. I am a qualified lead auditor (EN ISO 13485:2016) and have acted as an internal and supplier auditor according to ISO 13485 and/or FDA’s QSR as well as an internal trainer. I also have qualification from Finas to act as a technical expert according to standards SFS-EN ISO/IEC 17025:2017, SFS-EN ISO 15189 and SFS-EN ISO/IEC 17020.
Quality and Regulatory Affairs Manager
Certified ISO 13485:2016 Lead Auditor
I am a medical device professional with almost 20 years experience in product development, quality and regulatory affairs. I have a M.Sc. degree in materials engineering and wide experience in different device types such as implantable devices, electrical devices, instruments and software.
I work with the manufacturer to create design documentation, which fulfills the requirements of the target market area. This includes for example risk management, design verifications and validations, process validation, usability engineering file and clinical evaluation. I compile the technical documentation for CE-marking or FDA-submission and keep contact with the Notified body or regulatory authorities.
I have also helped several companies to create or develop their quality management system to comply with the ISO 13485 and FDA QSR. I have a lot of experience in conducting internal audits, also according to MDSAP.
Chairman of the Board
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.
Manager of Regulatory Affairs
I am a specialist in sales approvals and registrations of in vitro diagnostic medical devices (IVD) and in quality systems. My responsibilities include registration strategies for IVD and medical devices (e.g. EU and USA) as well as planning and reporting of verification and validation studies of IVD products. I have a M.Sc. degree in biochemistry.
I have almost 30 years of experience in IVD industry, especially in quality and regulatory affairs. I am an experienced lead auditor and I can audit according to ISO 9001 and ISO 13485 standards, USFDA QSR and Canadian CMDCAS.
Product development specialist
I am specialist in project management, R&D and testing. I have soon 20 years of experience in these topics within medical device field and other industry. I have gained a good overall view of the medical device industry and a deep inside into the product registrations. My expertise lies in design control, testing methodology and its development, data visualization and statistical analysis. Currently, I have focused on software registrations and impact of the new medical device regulation on the software products.
I am a specialist in sales approvals and registrations of in vitro diagnostic medical devices (MD and IVD). I work with the initial-, change- and renewal registrations of IVDs and medical devices worldwide (eg Eu, China, South Korea, Malaysian, Singapore, Saudi Arabia, Iran, Ukraine, Sudan). One of my tasks is also monitoring the regulations of various countries.
I have M.Sc. degree in biochemistry. Nearly 30-year career I have done in IVD industry, in relation to the whole product life cycle from product development to manufacture, without forgetting the quality management. Observing the authority regulations is naturally an important part of my work. I have a long experience in planning and reporting verifications and validations during the development of IVD products as well as in validation of production equipment. I have also worked 10 years as an internal auditor.
Quality and Regulatory Specialist
I am an expert on medical device quality systems and regulations. I have 30 years of experience in the development, manufacture and use of diagnostic equipment in hospitals. I have looked the diagnostics industry as the end user in hospital laboratories and as a global IVD manufacturer management team member. I’m specialized in the consideration and successful implementation of various quality system requirements for manufacturers and laboratories in their own systems.
I am specialist in research, development, and quality management. I have experience in MD and IVD industry among surgical instruments, implants and nucleic acid based IVD products. I am familiar with the whole life cycle of the products, including product development, production processes, quality assurance and post-market surveillance. My special expertise is in the fields of product risk management, QMS requirements (ISO9001, ISO13485), internal auditing, and cleanroom maintenance and control (ISO14644, GMP). I have also strong scientific background with doctoral thesis focused in genetics.
Certified ISO 13485:2016 Lead Auditor
I am a medical device professional with versatile experience over 15 years in the medical device industry. I have held positions in Quality, Product development, Product management, Sales and Marketing, which have given me understanding of the medical devices all the way from early product concepting together with medical professionals, to development and commercialization of the devices in global markets.
I support our clients (MD/IVD) in their quality and regulatory work, from creation and development of quality management systems according to ISO 13485 and US FDA QSR, to building design and technical documentation according to the target market.
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 FDA.
Quality Systems from Scratch
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.
- We wrote process descriptions according to the customer’s functions and created new process descriptions for functions that they did not have yet.
- Together with the customer, we chose the Notified Body that could certify the system in accordance with the ISO 13485 and CMDCAS standards. The quality system that we prepared also fulfilled the FDA QSR requirements for the United States.
- Together with the Notified Body, we did a preview of the system and received confirmation that we had covered all the necessary issues.
CE-marking, Class III
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.
- Based on the prepared documents we wrote, for example, validation and verification reports and a risk management and clinical evaluation together with the customer’s specialists.
- We prepared a design dossier and sent the application in paper and in electronic form to the customers’ Notified Body.
Global Sales Approval Plan
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.
- In our customer’s product idea, every product generation enables better care for the patient.
- The roadmap we made covers the effects of the increasing risks and technical demands on acquiring sales approvals globally in new product versions. We took national requirements into consideration in the roadmap.
- We keep our customer up to date on the changing legal requirements throughout the whole project.