References

Some of our customers:

Approval of medical devices / CE marking

Product documentation / technical documentation for CE marking of medical devices of class IIb in the field of hemodynamical monitoring in a global corporation.

Product documentation / technical documentation for CE marking of blood pressure meters (class I with measuring capacity) in a medium sized medical device manufacturer.

Strategic consultation and support of CE marking of medical devices in various start-ups in the field of medical technology.

Preparation of product documentation for CE marking of standalone-software for the joint use with IVDs.

QM Systems

Development and implementation of a tool-based graphic QM-system according to DIN EN ISO 9001 and DIN EN ISO 13485 for an international manufacturer of medical devices in the field of wound and stoma care.

Preparing a QM-system according to DIN EN ISO 13485 for a manufacturer of dental devices.

Preparing and implementing a customized QM-system according to Good Clinical Practice (GCP) and DIN EN ISO 13485 for a newly founded clinical research department in a global medical device manufacturer.

Quality Management and Regulatory Affairs

Continuous counseling and support of the QM/RA department of a middle-sized high-tech company.

Function as external QM-advisory at a German medical device manufacturer.

Risk Management

Development and implementation of a method for modular risk management according to DIN EN ISO 14971 for medical software and support during execution of risk analysis. Development and integration of a method for determining software-security classification according to DIN EN 62304 into the risk management system of a manufacturer of ultrasound-software.

Implementation of a method for risk management and presentation of risk management activities for risk-assessment of blood pressure meters.

Interactive graphic QM-system

Development and implementation of a graphic and interactive QM-system according to EN ISO 9001 and EN ISO 13485 for an international manufacturer of medical devices in the field of wound and stoma care.

Management Review

Definition of an electronic work flow chart for tracking of measures via issue-tracker for implementing a continuous management review in a middle-sized medical device manufacturer.

Supporting preparation of management review and subsequent presentation in a global medical device manufacturer of surgical dressings.

Training

Conducting inhouse-trainings and workshops with respect to Medical Devices Directives, medical device consultant, security officer for medical devices, quality management and risk management for numerous clients.

Internal audits

Developing and conducting internal audits as well as monitoring certification audits for numerous clients.

GAP-analysis

Executing a GAP-analysis of technical construction file and QM-system with respect to compliance with relevant norms and directives for medical devices. Implementation of measures out of the GAP –analysis in preparation for the certification audit at a private label manufacturer of medical devices of class IIa.

Supplier management / Supplier audits

Development of a risk-based method for assessing and supervising suppliers.

Support and execution of supplier audits.

Traditional / Special 510(k)

Product classifications and research of relevant guidances and guidelines as well as predicate devices; preparing and submitting of traditional 510(k) files at the FDA for a middle-sized medical device manufacturer (OP-lamps of class II). Research on adequate product codes and predicate devices for a medical device manufacturer in the dental field.

Research on relevant guidances and guidelines as well as predicate devices for a manufacturer of surgical instruments.

U.S. Agent

Search for adequate US-agents for a middle-sized medical device manufacturer.