Patent your ideas

The intellectual property of a company is both a value component and a vital asset in a competitive market. For this reason it is imperative to protect your knowledge and investments in new products and processes.

We can help you patent your inventions, secure a portfolio of industrial property rights for your new product and handle all the necessary steps on your behalf.

Our knowledge – your asset

Our in-depth knowledge is at your disposal even if you are not outsourcing a product development project. Because we know that delays in the licensing process can be very expensive. So make the most of our wealth of experience, and we’ll help you achieve your goals faster. We give top priority to a collaborative, transparent and efficient partnership.

Advice and support for product licensing

We can help prepare your product for testing and certification for the relevant country in line with international requirements such as:

• CE conformity (European market)
• FDA compliance (US market)
• CSA certification (Canadian market)

We can provide advice on a wide range of issues relating to standards and certification:

• Quality management in accordance with EN ISO 13485 and 21 CFR 820
• Quality System Regulation
• Risk management in accordance with EN ISO 14971
• Software development in accordance with EN 62304
• Usability in accordance with EN 62366
• Integration of medical products in hospital IT networks in accordance with EN 80001
• Clinical evaluation in accordance with MEDDEV 2.7.1
• Post-marketing surveillance / vigilance in accordance with MEDDEV 2.12-1
  
  

Expanding your employees’ know-how

To make high-quality products you need highly trained people.

We will provide staff training at your own premises, tailored to your company and specific issues affecting your business. Some examples of topics include:

• Establishing quality management processes
• Working with new or changed process and product standards
• Internal training / audits prior to certification
• Support for supplier training
• Getting you ready for FDA

Getting you ready for FDA

Why not make the most of our experience in FDA compliance in your product licensing process?

We can assist you in the following areas:

• Gap analysis to identify potential gaps in the quality management system or documentation (21CFR 820)
• Advice on setting up an FDA-compatible quality management system
• Production of licensing documents (e.g. 510(k) files)
• Advice on FDA-compliant software development and evaluation of existing software and related documentation