STARTUP SERVICES

WE HELP YOUR BUSINESS

Our team has a vast amount of experience from enabling startup companies or projects in their early stages to enter the markets sooner. We have helped our startup clients to proceed to the sales phase faster by reassessing the uses of their products and examining the product’s classification. By doing this, we have found new and quicker routes for starting up sales.

For startup clients, we build the necessary quality management system, compile the technical documentation that leads to a CE marking, carry out registrations, give financial advice and help in applying for private and public funding by connecting you to our own contact network.

We also often help startups build their subcontractor network and sales channel.

The clinical investigations we manage are monitored by our CRAs.

WE ARE EXPERIENCED COMPILERS OF TECHNICAL DOCUMENTATION

MDS compiles and maintains the technical documentation of your company’s medical device. The technical documentation must be compiled when you apply for the CE marking, and maintenance is mandatory to retain the CE marking. Our consultants take care of all areas of technical documentation.

QUALITY MANAGEMENT SYSTEMS

We have built dozens of ISO13485, ISO9001, ISO14001 and QSR(US) -compliant quality management systems for companies manufacturing various types of medical devices.

According to the MDR, a quality management system is mandatory for all medical device manufacturers. A well-built quality management system helps your company operate in a systematic manner and increases efficiency.

CLINICAL DEVICE INVESTIGATION

On behalf of our client, we compiled a clinical investigation protocol with appendices (CRFs), acquired the ethical statement for the investigation and made an agreement for between the client and clinical unit.

We submitted the device investigation notifications to the authority and established the clinical investigation in the digital management system for clinical investigations where we can monitor the customer’s investigation and its quality in the role of a CRA.

We also notified the investigation in ClinicalTrials.gov.

FINANCIAL ADVICE

We were once startup entrepreneurs within medical technology and implemented various funding rounds in an international operating environment. We are also familiar with the sources of public funding.

We utilize this competence by helping you create sensible project phases by keeping in mind the increase in your company value and help you build implementable scenarios.

EC REP

Our company can operate as the local representative for healthcare products from outside the EU. We take care of the bureaucracy related to placing products on the market and keep the CE marking up to date.

CASE EXAMPLE

REASSESSMENT OF PLACING ON THE MARKET

Our client wanted to enter the markets with a CE-marked Class IIa product. We assessed the product and noticed that by limiting the clinical indication somewhat, the product could be placed on the US markets as a Class I (FDA) product. We were able to register the product for the US markets in a few weeks, and our client was able to start selling their product.

By utilizing a parallel market area, we could continue the registration in the EU while securing the company’s cash flow.

When our client’s company received permission to start sales in the EU area 12 months after the US registration, their US sales had already reached almost one million euros.