Network of specialists

We know who knows even more than we do – for the right solution to your Product Compliance and Standards Management challenge.

Setting new standards with strong partners

We work in cooperation with selected partners from industry and science – maintaining a constant dialog on the latest developments as well as linking theoretical guidelines to a practical approach.

In addition, we're actively involved in influential professional associations and interest groups focusing on STANDARDS and COMPLIANCE.  Reciprocal knowledge exchange of our experts with their peers at the leading organizations shown below ensures that we too are constantly expanding our horizons. This gives us the capacity to fulfil your specific requirements – in relation to a particular industry, locally or globally.


Our network

ISS AG

ISS AG, Integrated Scientific Services provides services to medtech companies for the development of medical devices, their introduction into the market and their maintenance. Typical services include embedded software development, regulatory affairs and clinical evaluation report writing, clinical research, quality management, qualification and validation. The combination of these services with scientific work methods and project management puts ISS AG into a unique position as a service provider for the medtech industry.

» www.iss-ag.ch/de

Phoenix Contact

Phoenix Contact is the global market leader for components, systems and solutions in the field of electrical engineering, electronics and automation. In addition to the core business, a separate service sector has been established for several years. The Competence Center Services offers product-independent services and seminars for machine manufacturers, system integrators and operators.

» www.phoenixcontact.de

3R LifeScience

3R LifeScience is a management consultancy in Berlin that supports medical technology companies and companies in the health sector with product development or the further development of the company - from the spin-off to establishment and successful growth. Whether for ambitious start-ups or international groups - everyone benefits from the proven combination of in-depth specialist knowledge with tried and tested management skills.

» www.3r-lifescience.com

gds – Global Document Solutions

GDS specializes in applied software solutions and services in the field of technical documentation.  Our focus is on process optimization and increasing organizational efficiency.

Our docuglobe editorial system is used by over 400 companies, providing consistent, quality-assured documentation as well as considerable cost savings.  Preparation of documentation conforms to relevant Standards and ranges from operating manuals to risk assessments.  gds Sprachenwelt provides certified translation and language services.

» www.gds.eu

Conformance Limited

Conformance Limited is one of the UK's leading independent advisory agencies in CE marking, product safety and environmental issues.

We have over 15 years' experience in the CE marking industry and have to date assisted more than 3,000 companies in fulfilling the necessary requirements for their products.

Our specialized consultants cover the full range of CE Directives – machinery, production lines, work equipment, electrical / electronic devices, pressure equipment and ATEX / DSEAR, medical devices, and toy safety – as well as all the environmental Directives.
 
Our approach is highly adaptable, enabling us to help small, home-based businesses to certify their products themselves just the same as we can monitor safety at a steel rolling mill.  We can provide solutions for every conceivable product.

» www.conformance.co.uk

Schmeling + Consultants GmbH

Schmeling + Consultants GmbH advises companies on quality assurance, legal conformity and technical information management, as well as information systems and processes for successful technical communication.  Superior competence in content preparation, methodology and transfer of expertise, as well as comprehensive training and further education of editorial staff form the focus of our consultation.

Accurate research on the global requirements of technical documentation to ensure their correct implementation is at the heart of our partnership with GLOBALNORM.

» www.schmeling-consultants.de

Compliance inSight Consulting Inc.

Compliance inSight Consulting Inc. specializes in risk assessment of industrial machinery in accordance with current EU and US and Canadian regulatory requirements.

Services include consultancy, other risk assessments, safety reviews, functional safety analysis and training courses.

» complianceinsight.ca

Together we'll master your challenge efficiently and effectively.  Contact us!

More on Standards and Product Compliance
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Unclear when they will appear in the EU Official Journal

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SCiP database in accordance with Directive 2018/851/EU coming soon

Still lots of unanswered questions

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