Medical device class IIa - Image Guided Diagnostic

Aufgaben:

Aufgaben:

• Implementation and certification of the company according to ISO 13485
• Preparation of technical file (DHF, DMR) according to 93/42/ EC
• Product registration according to 93/42/ EC
• Improvement of risk management according to ISO 14971
• Conduction of risk management workshops and risk management
• Implementation of Usability process according to IEC 62366
• Conduction of usability workshops and usability process monitoring
• Compilation of clinical evaluation according to EN 14155 and MEDDEV 2.7.1
• Implementation of UDI requirements

Medical device class IIa ? Enteral Nutrition

Aufgaben:

• Implementation of CAPA, Complaint and Medical Device Vigilance system
• Improvement of site-specific quality management system
• Support of safety officer (according to §31 of German medical device law)

Medical device class IIa - Dialysis

Aufgaben:

• Preparation of product documentation (DHF, DMR) and the corresponding 510(k) approval
• Preparation of technical file (DHF, DMR) according to 93/42/ EC
• Conduction of risk management workshops according to ISO 14971
• Implementation of CAPA, Complaint and Medical Device Vigilance system

Aufgaben:

• Implementation and certification of the company according to ISO 13485
• Preparation of technical file (DHF) according to 93/42/ EC
• Implementation of a development process according to ISO 60601-1 and IEC 62304
• Implementation of risk management according to ISO 14971
• Conduction of risk management workshops
• Implementation of Usability process according to IEC 62366
• Conduction of usability workshops
• Compilation of literature based clinical evaluation according to EN 14155 and MEDDEV 2.7.1

Aufgaben:

• Improvement of QM Systems according to ISO 13485
• update according to ISO 13485:2016 and MDR requirements
• Examination of product documentation (DHF, DMR) according to 93/42/ EC
• Preparation of product documentation (DHF, DMR) and the corresponding
• 510(k) approval
• Conduction of risk management workshops
• Improvement of risk management according to ISO 14971
• Preparation and update of technical file (DHF, DMR)
• Implementation of CAPA, Complaint and Medical Device Vigilance system
• Implementation of Usability process according to IEC 62366
• Implementation of UDI requirements
• Implementation of MDR requirements
• Preparation of MDSAP audit

Medical device class I, IIa - Ophthalmology

Aufgaben:

• Examination of product documentation (DHF, DMR) according to 93/42/ EC
• Preparation of product documentation (DHF, DMR) and the corresponding
• 510(k) approval
• Improvement of risk management according to ISO 14971
• Conduction of risk management workshops and risk management
• monitoring Implementation of Usability process according to ISO 62366
• Conduction of usability workshops and usability process monitoring
• Implementation of V-Model according IEC 62304 in a pilot project
• Introduction of a requirement management system in a pilot project
• Compilation of documentation necessary for worldwide product registration
• Compilation of clinical evaluation according to EN 14155 and MEDDEV 2.7.1
• Preparation of MDSAP audit

Medical device class I, IIa - Ophthalmology

Aufgaben:

• Examination of product documentation (DHF, DMR) according to 93/42/ EC and MDR
• QMS update according to ISO 13485:2016 and MDR requirements
• Preparation and update of technical file (DHF, DMR)
• Implementation of CAPA, Complaint and Medical Device Vigilance system
• Improvement of risk management according to ISO 14971
• Implementation of Usability process according to IEC 62366
• Compilation of documentation necessary for worldwide product registration (FDA, CFDA, JPAL etc)
• Compilation of clinical evaluation according to EN 14155 and MEDDEV 2.7.1

Medical device class IIa - Magneto therapy

Aufgaben:

• Implementation and certification of the company according to ISO 13485
• Product registration for European (93/42/EC) and South Eastern Asian market
• Preparation of technical file (DHF, DMR) according to 93/42/ EC
• Compilation of clinical evaluation according to EN 14155 and MEDDEV
• 2.7.1
• Support of safety officer (according to §31 of German medical device law)
• Conduction of training for European sales partners regarding medical device regulation.

Medical device class IIb ? Ventilation

Aufgaben:

• International registration of products
• Creation of STED file

Medical device class IIb - Ventilation

Aufgaben:

• Preparation and update of technical file (DHF, DMR) for EU and FDA approval
• Implementation of CAPA, Complaint and Medical Device Vigilance system
• QMS update according to ISO 13485:2016 and MDR requirements
• Definition of regulatory strategy
• Implementation of risk management according to ISO 14971
• Implementation of Usability process according to IEC 62366
• Implementation of Software development process according to IEC 62304
• Improvement of site specific quality management system

Medical device class IIb ? Therapeutic Laser

Aufgaben:

• Implementation of site-specific quality management system according to EN
• ISO 13485:2016 and MDR requirements
• Preparation and update of technical file (DHF, DMR)
• Implementation of CAPA, Complaint system
• Update of market surveillance and vigilance system according to MEDDEV 2.12.1
• clarification of EU representative responsibilities
• Implementation of UDI (FDA / EU) requirements
• Implementation of MDR requirements
• Implementation of MEDDEV 2.7.1 rev4 and update of corresponding Clinical
• Evaluation documents
• Preparation of MDSAP audit

Medical device class IIa ? Dentistry products

Aufgaben:

• International registration (e.g. FDA, CFDA, CIS) of various products
• Creation of STED file

In vitro diagnostic

Aufgaben:

• OEM product approval for European market of different IvDs

Medical Devices class I, IIa

Aufgaben:

• OEM product approval for European market of different medical devices

Medical device class IIa, IIb - Dialysis

Aufgaben:

• Update of Quality Management System according to MDR
• Update of Quality Management according to 13485:2016
• Preparation and update of technical file (DHF, DMR)
• Implementation of CAPA, Complaint system
• Clarification of EU representative responsibilities
• Implementation of MEDDEV 2.7.1 rev4 and update of corresponding Clinical
• Evaluation documents
• Preparation of MDSAP audit