Medical device and&nbsp;IVD regulatory services &#8211; from QMS to technical documentation and product registrations

Medical device and IVD regulatory services

Implementation and maintenance of Quality management system according to ISO 13485

Most major markets require implementation and maintenance of a quality management system (QMS). With our help, you can meet the specific QMS requirements in different markets around the world. ISO 13485 is an international quality management system standard for medical devices that has been developed to meet the specific needs of the industry. Several markets, however, have their own specific requirements.

Let us help you in establishing and implementing the requirements in your market areas into an efficient QMS system by:

Providing an ISO 13485-based QMS package
Consulting on requirements, establishment and implementation of quality management system
Performing quality management system pre-audits, audits and gap analyses
SOP writing, review and consultation.

You may also outsource the tasks of quality manager or quality specialist to us, including the following:

Coordination of internal audit programs and conducting internal audits
Coordination of supplier management and conducting vendor and supplier audits

Technical documentation for medical devices and IVDs

Medfiles offers a wide range of services related to the technical documentation of medical devices and IVD medical devices. Whether you need to draw up technical documentation for a new device or bridge the gap between the existing documentation and regulatory requirements, or you have specific questions regarding the technical documentation, we are happy to help.

If you want to CE mark your medical device and place it on the market in the EU, the technical documentation must comply with the applicable requirements in the Medical Device Regulation (EU) 2017/745 (MDR) or the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR).

Other markets outside the EU have their own requirements for the device’s technical documentation. We can assist you in compiling and managing the technical documentation of your medical device or IVD medical device also outside the EU.

To make sure your documentation will comply with the applicable requirements, we can perform a gap analysis between your existing technical documentation and requirements of the MDR/IVDR in the EU or other applicable requirements in the markets outside the EU. We can also assist you in drawing up the technical documentation for your device, including the following:

device description and specifications
labelling
packaging and instructions for use
general safety and performance requirements (GSPR) checklist
risk management documentation
documentation related to product verification and validation
documentation on post-market surveillance (PMS).

You can ask us specific questions related to the technical documentation of medical devices and IVD medical devices, such as questions concerning the structure of the technical documentation or the requirements of a specific area of the technical documentation, such as risk management. If you need a review for your technical documentation, we can make sure it meets the regulatory requirements of the MDR/IVDR or the applicable legislations in the markets outside the EU.

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Clinical evaluations for medical devices and performance evaluations for IVDs

Clinical evaluation or performance evaluation is an essential part of the conformity assessment of medical devices and IVD medical devices and mandatory according to the applicable EU regulations: the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR). Our experts can help you to meet these clinical evaluation and performance requirements.

In the recent years, the bar has been rising for clinical data requirements both in the EU and outside the EU, and the question of whether there is enough clinical data available from equivalent products or if clinical investigations are needed is of critical importance. No matter if you plan to tackle the requirements with review of published literature or clinical investigations of your own, we can provide the expertise and resources in:

Creating product-specific strategies to meet clinical data requirements
Writing clinical evaluation and performance evaluation plans and reports
Planning, performing and reporting systematic literature reviews
Clinical investigations and performance studies
Writing post-market clinical follow-up (PMCF) and post-market performance follow-up (PMPF) plans and reports and assisting in PMCF/PMPF activities

Clinical Evaluation

Performance Evaluation

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Medical device and IVD product registrations and CE-marking

Place your medical device or IVD medical device on the market successfully around the world with the help of our services. By utilising our team’s extensive experience in your product development projects, you can be sure that all regulatory requirements are considered early on from the start. We can make sure that your product is compliant with the regulatory requirements in various markets, both in the EU and outside of the EU.

Our team is experienced in successful product registrations in cooperation with local representatives in several markets around the world. Whether you want to outsource the whole registration process or need answers to specific questions about product registration in the different markets, let us help you.

When you need to determine the intended purpose of your product, create a regulatory strategy or select suitable procedures for the conformity assessments for your product, you can rely on our expertise. We can also assist you in product classification, including borderline products and drug-device combination products, and switching product classification for example from a medicinal product to a medical device.

Wherever you intend to sell your medical device or IVD medical device, we can compile the specific registration documents needed for each market around the world. If you plan to place your product on the market in the EU, we can help with CE-marking your product according to the MDR/IVDR, and when you aim for the market in the USA, we can assist you in the FDA 510(k) process and compliance with the 21 CFR Part 820.

You can ask us specific questions about product registration in the different markets around the world, and we can help you by keeping an up-to-date list about the different laws, guidelines and standards about medical devices and IVD medical devices for any country you need. Once your product is on the market, you can outsource your maintenance tasks to us. Medfiles also provides comprehensive authorised representative services according to the MDR and IVDR requirements for device manufacturers from outside of the EU.

AI-assisted medical device gap analysis

Preparing for MDR/IVDR certification or bringing a medical device to market often begins with understanding how well your existing documentation meets current regulatory requirements. To support your certification projects, we offer medical device gap analysis using our in-house tool, which combines AI-assisted analysis with expert regulatory review.

Our solution quickly compares your technical documentation against applicable MDR/IVDR requirements, highlighting missing or insufficient elements in a structured way. Every AI-assisted analysis is reviewed by qualified regulatory experts, ensuring reliable, regulatory-compliant conclusions.

The assessment provides clear, prioritised recommendations, helping you focus resources on the areas most critical for certification and market access. By reducing the time required for manual document reviews, it supports faster project timelines while allowing our experts to focus on high-value regulatory evaluation. The tool is built on EU-hosted infrastructure with GDPR-compliant processing, which ensures that your confidential information remains protected throughout the assessment.

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Post-Market Surveillance and Vigilance Services for Medical Devices and IVDs

Establishing a compliant post-market surveillance (PMS) system is essential for maintaining the safety and performance of medical devices and in vitro diagnostics (IVDs). Our experts can support you in establishing and developing your post-market processes or if you need an extra pair of hands, you can outsource parts of your process to us.

Our services include:

Consultation on post-market surveillance (PMS), post-market clinical follow-up (PMCF) and post-market performance follow-up (PMPF)
Consultation and guidance on vigilance procedures and regulatory compliance
Coordination and management of post-market surveillance activities
Execution of specific PMS, PMCF, and PMPF tasks, including systematic literature reviews and vigilance database searches
Preparation and maintenance of Periodic Safety Update Reports (PSURs)
Processing and reporting of incidents and field safety corrective actions

Labelling, marketing materials and translations for medical devices and IVDs

The labelling of medical devices is an essential element in the medical device regulation. It plays an essential role in the conformity assessment process, as well as in ensuring the identification and traceability of devices on the market. Detailed labelling requirements for medical devices are outlined in Annex I of the MDR and IVDR, which define the general safety and performance requirements. Additionally, the harmonised EN ISO 15223-1 standard specifies the symbols and information that must appear on the labels of medical devices.

Our service responds especially to the challenges posed by national and local legislation, and we use our years of experience in reviewing marketing texts and labelling. Content is always reviewed by a medical device and in-vitro device expert, so you can be confident in the correctness and compliance of the content. We give clear feedback for your materials, evaluate the potential risks and offer solutions to overcome them. Our experts have extensive experience in various types of marketing materials and working with businesses of all sizes, from small pharmaceutical companies to large-scale multinational enterprises.

We also offer translation services for all types of texts related to MD and IVD. We prepare translations in accordance with all applicable authority regulations and ensure that the content and language of the translations is correct. Translation quality and usability are our priority. Our in-house working languages are English, Finnish, Swedish, Estonian, Latvian and Lithuanian, and with the help of our hand-picked partner network, we can deliver texts in many other languages.

The service is always tailored to the client’s needs, and content can be produced either on a one-off basis or on an ongoing contract.

See also:

Insights for importers and distributors: regulatory compliance, labelling and marketing materials

Training on requirements and regulatory environment for medical devices and IVDs

Continuous competence development is essential in a rapidly changing operating environment. Medfiles provides high-quality and timely training for companies in the MD and IVD industries. Ask for training tailored specifically to your team or company.

Possible topics could be for example:

CE marking process of medical devices – requirements and best practices
Medical Device Regulation 2017/745 and In Vitro Diagnostic Regulation 2017/746
EN ISO 13485:2016
21 CFR Part 820 (QSR)
Support and coaching for your quality or regulatory affairs personnel.

We will be happy to make you an offer on the desired topic.