Regulatory Experts for Medical Devices | YES Medical Device Services

<img src="../wp-content/uploads/2020/10/YES-MDS_ICONS-1.png" /> EU & Worldwide

We pave the way to a CE mark for the European market as well as the international registration of your medical devices.

Product classifications
Demarcation expert opinion (e.g. borderline medicinal product/medical devices)
Technical documentation (according to MDR or STED according to IMDRF)
- Clinical Evaluation
- Assessment of biocompatibility
International regulatory documentation (e.g. for USA, Canada)

<img src="../wp-content/uploads/2020/10/YES-MDS_ICONS-2.png" /> Quality management

We are your partner to implement a quality management sytem in accordance with all regulatory requirements or to update and optimize your existing system. An efficient quality management system helps to optimize processes and forms the basis for the product approval as well as the product safety for medical devices.

Implementation of a quality management system according to ISO 13485
Updating and optimization of your quality management system
Procedures (SOP) and work instructions
Combination of GMP and ISO 13485
Internal audits as well as supplier audits

<img src="../wp-content/uploads/2020/10/YES-MDS_ICONS-3.png" /> Maintenance

We maintain your technical documentation and keep your authorizations up to date. Consequently, you are always well prepared for audits and visits of authorities.

Updating your technical documentation

Review and analysis of the current regulatory requirements

Search for standards

Search for literature

<img src="../wp-content/uploads/2020/10/YES-MDS_ICONS-4.png" /> Post-Market- Surveillance

Through proactive market surveillance (e.g. literature monitoring), we inform you in time about critical data from the literature and incidents with similar products, enabling you to react immediatly and responsibly. We support you in handling incidents or in setting up and maintaining your vigilance system. Thus you report the right things to the right authority at the right time.

Active market observation
Periodic and systematic literature monitoring
Medical device monitoring and notification systems, vigilance
Regulatory notifications to authorities
Post Market Surveillance (PMS) Report
Periodic Safety Update Report (PSUR)
Post Market Clinical Follow-Up (PMCF)

EU & WORLDWIDE

We pave the way to a CE mark for the European market as well as the international registration of your medical devices.

Product classifications
Demarcation expert opinion (e.g. borderline medicinal product/medical devices)
Technical documentation (according to MDR or STED according to IMDRF)
- Clinical Evaluation
- Assessment of biocompatibility
International regulatory documentation (e.g. for USA, Canada)

Qualitymanagement

We are your partner to implement a quality management sytem in accordance with all regulatory requirements or to update and optimize your existing system. An efficient quality management system helps to optimize processes and forms the basis for the product approval as well as the product safety for medical devices.

Implementation of a quality management system according to ISO 13485
Updating and optimization of your quality management system
Procedures (SOP) and work instructions
Combination of GMP and ISO 13485
Internal audits as well as supplier audits

Maintenance

We maintain your technical documentation and keep your authorizations up to date. Consequently, you are always well prepared for audits and visits of authorities.

Updating your technical documentation
Review and analysis of the current regulatory requirements
Search for standards
Search for literature

Post-Market-Surveillance

Through proactive market surveillance (e.g. literature monitoring), we inform you in time about critical data from the literature and incidents with similar products, enabling you to react immediatly and responsibly. We support you in handling incidents or in setting up and maintaining your vigilance system. Thus you report the right things to the right authority at the right time.

Active market observation
Periodic and systematic literature monitoring
Medical device monitoring and notification systems, vigilance
Regulatory notifications to authorities
Post Market Surveillance (PMS) Report
Periodic Safety Update Report (PSUR)
Post Market Clinical Follow-Up (PMCF)

We are certificied according to ISO 9001-2015 by DQS (Certificate-Registration-No. 506233 QM15).

Dr. Karin Lübbers
Managing Director

At YES, we think entrepreneurially and take responsibility for our actions. Customer expactations and quality standards are met on the basis of international regulations for medical devices, legal requirements and ethical values.

At YES, we are a team – every team member is equally valued and respected. With our knowledge, skills and experience, we all contribute to the company’s success. Flexible working hours and a pleasant, family-like working environment are of additional importance for us.

CE-marks for medical devices – Conformity to the MDR

YES Medical Device Services GmbH | Am Houiller Platz 4 A | 61381 Friedrichsdorf, Deutschland | Telefon +49(0)6172-2655900 | Fax +49(0)6172-2655890 | info@yes-mds.de

Our Services

EU & Worldwide

Quality
management

Maintenance

Post-Market-
Surveillance

Our Services

EU & WORLDWIDE

Qualitymanagement

Maintenance

Post-Market-Surveillance

ISO 9001

Management

About us

News | CAREER

CE-marks for medical devices – Conformity to the MDR

Contact

YES Medical Device Services GmbH | Am Houiller Platz 4 A | 61381 Friedrichsdorf, Deutschland | Telefon +49(0)6172-2655900 | Fax +49(0)6172-2655890 | info@yes-mds.de

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