Outsourcing - Regular Services

We are happy to relieve you of your tasks in the areas of regulatory affairs or quality management.

Proof of a conforming medical device and a conforming quality management system are the basic requirements for approval and marketing. Outsourcing means that we relieve your company of these tasks, so you can focus on your core competencies. Below is an overview of the areas in which we can support you:

Regulatory Affairs

Faster approval of your medical device in the marketing areas is not only a decisive competitive advantage, but also a guarantee for growth and profit. Outsourcing means that we relieve your organization from tasks in the areas of regulatory affairs, quality management and project management and that you can focus on your core competencies. Below is an overview of activities that we will be happy to take care of for you:

Details

Feel free to put together your topics and send your request at the bottom of the page.

Regulatory Affairs Selection

Compilation and editing of technical documentation for CE

Compilation and editing of technical documentation for international approvals

Handling of the complete national or international approval of your medical device

Classification of medical devices, taking into account their intended purpose, indications and marketing area

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Quality Management

A conforming quality management system contains all processes for the implementation of regulatory requirements. The quality management system must always be up to date with the latest regulations and must be regularly reviewed and maintained by the company. Below is an overview of activities in the field of quality management:

Details

Feel free to put together your topics and send your request at the bottom of the page.

Quality Management Selection

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Clinical Evaluation

Clinical evaluation as primary proof of the intended purpose of your medical device is subject to a large number of regulatory requirements. With the start of the marketing of the medical device, the clinical evaluation must be continuously updated. Below is an overview of activities for the initial preparation of the clinical evaluation as well as further care:

Details

Feel free to put together your topics and send your request at the bottom of the page.

Clinical Evaluation Selection

Preparation of a clinical evaluation report according to MDR (2017/745)

Preparation of a clinical evaluation report according to MEDDEV 2.7.1/4

Conducting a Clinical Literature Search

Conducting a search for equivalent or similar medical devices in accordance with MDR (2017/745)

Preparation of a post-market surveillance plan according to MDR (2017/745)

Preparation of a safety report according to MDR (2017/745)

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Regulation-research

Regulatory requirements are contained in standards, Common Specifications (CS), laws, regulations, directives, implementing acts, guidelines and recommendations. We research for you which We identify which of the hundreds of regulatory requirements are to be applied specifically for your medical device and your quality management system. Below is an overview of activities for researching regulations:

Once-off research of applicable regulations. Search of standards, common specifications, laws, regulations, directives, implementing acts, guidelines and recommendations. We offer research for many marketing areas, e.g. EU (CE area), standards for proof of "state of the art", USA, Canada, and many more.

Regulatory requirements update service – Regular research of applicable regulatory requirements. You will receive regular information about new or amended standards, common specifications, laws, regulations, directives, implementing acts, guidelines and recommendations with our update service. In addition, you will receive GAP analyses of substantive changes.

Details

Feel free to put together your topics and send your request at the bottom of the page.

Regulation Research Selection

Regulation research – once-off

Regulation research – Update Service

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Vigilance research

Vigilance requirements regulate the obligation to report incidents or recalls to competent authorities in the marketing areas. Vigilance requirements are not uniform worldwide and, moreover, are changed irregularly sporadically by the legislature of the individual marketing areas. Below is an overview of activities for researching current valid vigilance requirements:

Once-off identification of current legal vigilance requirements for incidents, recalls, FSNs and FSCAs. We offer research for worldwide marketing areas.

Vigilance Update Service – Regular research of vigilance requirements. With our vigilance update service, we regularly research current legal vigilance requirements for incidents, recalls, FSNs and FSCAs for you. In addition, you will receive GAP analyses of substantive changes.

Details

Feel free to put together your topics and send your request at the bottom of the page.

Vigilance research Selection

Vigilance research – once-off

Vigilance research – Update Service

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GAP analyses

Are you conforming with current valid regulations? GAP analyses are a valuable assistance to answer this question. Our specialists compare your company's product documentation and/or QMS documentation with applicable regulations and show you any necessary improvements. All our GAP analyses not only show the required improvements, but also contain practical proposals to close the GAPs. Below you will find an overview of GAP analyses that we will be happy to carry out for you in German or English:

Details

Feel free to put together your topics and send your request at the bottom of the page.

GAP analysis product/QMS versus set of rules selection

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Are you interested in our offer?

If you have compiled all the desired contents of this service, then contact us for a non-binding and free offer. We look forward to hearing from you.

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Stay compliant. Use our update service and stay compliant with regulatory requirements.

We offer the update service for Regulation research, vigilance research, the regular services quality management system QMS Complete and clinical assessments.