About us

We provide professional consultancy services in the medical industry

As experienced medical industry employees, in the field of design, manufacturing and regulation, distribution and marketing, employees and experts of the competent authorities, notified bodies, the European Commission and consultants, we decided to join forces and create comprehensive services for manufacturers, importers and distributors in the medical industry. Our aim is to act to the full to introduce valuable products - from design through to implementation, registration and then post-marketing activities. After joining forces, we can successfully guide your company through the introduction of a new product and offer you comprehensive services.

On a daily basis, we provide consultancy services to companies from within and outside the European Union. As independent experts, we have all performed consulting services in the field:

10 Marketing and distribution activities in the medical industry

19 Quality systems implemented in the medical sector

14 Training courses
carried out

87 Products placed
on the market

278 Audits
carried out

323 Notifications
and notifications

Mission

Our mission is to provide the highest quality comprehensive marketing services for products supplied by EU and non-EU organisations. Our ultimate goal is not only to provide full support at the product introduction stage, but also to enable our customers to help them solve their problems effectively in the future.

We support innovation

Our work enables innovative medical companies to efficiently conduct the conformity assessment process and then introduce products that save patients' lives and health. We bring science, law and economics together.

We provide competitive advantage

Through our assistance in the implementation of quality systems, we take part in increasing the quality of manufactured products, we support the pursuit of continuous improvement, which helps our clients to gain an advantage over competing technologies.

„Primarily we are a partner and friend of our customers. Through an individual and customised approach to each case, we are able to fully assist our clients in developing and choosing the right path towards regulatory compliance.”

Vision

Customers trust MDR Regulator as a leading consulting company providing top quality services to all organisations in the medical devices, in vitro diagnostics, dietary supplements and personal protective equipment industry.

We provide support for growth

Support in launching products in the European Union, as well as support in expanding into non-EU markets, has helped our clients to grow and expand in the medical industry.

We are pleased to provide support on a key issue and create a supportive environment for the design and introduction of safe and effective products.

MEET US

Let's talk about cooperation

As a team of medical market specialists, we have a unique combination of experience in legal regulations, auditing, medical technologies as well as in business management and marketing. Thanks to our knowledge and experience, we are able to efficiently introduce the product to the EU market.

Katarzyna Wesołowska

Chief Executive Officer

A graduate of Biomedical Engineering at the Warsaw University of Technology and Clinical Research Methodology at the Medical University of Warsaw. Since the beginning of her career, she has been working in the medical industry. She has gained professional experience in healthcare companies and in the Notified Body. Active CE and ISO 13485 Auditor.

She knows how to effectively implement the MDR. Always looking for non-standard solutions.

Specialisation in areas:

MDR,
Authorised Representative UE,
Clinical evaluation,
CE Marking,
Quality Management Systems,
Non-EU market access,
Audits,
Trainings.

CONTACT KATARZYNA

Adrianna Pyrzanowska

Project Manager

A graduate of a Public Health. She has gained experience in the field of medical devices in the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, as well as by implementing many projects related to the introduction of medical devices on the market, providing support in the conformity assessment process.

She coordinates cooperation between MDR Regulator’s experts and clients.

Specialisation in areas:

IVDR,
Person Responsible for Regulatory Compliance,
UE product registration,
CE Marking,
Import and distribution,
Dietary supplements.

CONTACT ADRIANNA

We are a good team

At MDR Regulator we work together in support of a key issue. We are a team of a dozen experts with various experiences, so we are able to support our clients at every stage of introducing products to the European Union market.

We can help you during the following processes:

design,
risk analysis,
pre-clinical studies,
clinical trials,
clinical evaluation,
analysis of harmonised standards,
biological, chemical and physical tests,
biocompatibility,
safety and EMC testing,
biocompatibility of raw materials and finished products,
validation of manufacturing processes,
software validation,
technical documentation,
sterilization process validation,
consultation process during introduction of special products,
certification process,
implementation of a quality management system,
internal audits, audits of suppliers and subcontractors,
product registration,
post-market surveillance,
vigilance,
import and distribution,
as well as other activities that will enable you to enter your products on the EU market.

We provide professional advice on registration in non-EU markets

We also work with partners outside the EU, so we have the knowledge and experience to register products in the UK, Asia, North America, South America and Australia.