Bringing new products to market on time, at the right cost and quality while adhering to global legislation is paramount to companies in the medical industry.
The demand for easy to use, high quality products is constantly increasing. In a constantly changing globalized market the path to success has many challenges.
We can guide your development project from the first idea, through research and conceptualizing to the final approval of the product – now ready for market launch. We help you reach your targets through effective process management and knowledgeable consultants with an innovative mind-set. We have 15 years of experience improving product development processes for our customers.
Our expert teams operate within all areas of the product development process, e.g. Research & Development, Quality Assurance and Regulatory Affairs.
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“What you need is what you get” We offer you complete flexibility in accordance with your budget and the competencies required – you may need an extra resource for your projects or an expert for an extraordinary challenge – our consultants are used to working in cross-functional teams providing up-to-date expert knowledge often within a highly specialized field.
… and our track record demonstrates our successes – have a look
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Research and Development
R&D is an investment in your company’s future. Constantly having new products in pipeline is the key to developing your business and be in front of your competitors.
- Transform ideas into products
- Design for manufacturing
- User-centered design
- Ensure regulatory affairs
- Network / Production contacts
- Prototype build
- Visualization of concepts
Quality Assurance
Assuring the right quality in all aspects of your business is vital for your company’s image and success. We know the medical device business, and can help you ensure the right quality setup, e.g.
- QMS – Quality management system
- Audits
- Validation
- Business processes
- Training
Regulatory Affairs
Ensuring that your company complies with all of the regulations and laws pertaining to your business can be challenging. We can help you find your way round.
- Market access
- UDI (Unique Device Identification)
- CE and FDA Requirements
- Post market surveillance
- Stand alone software (determination of status and qualification)