Quality-on-site.com

A set of risk management templates including FTA- and HA-FMEA-style analyses, risk management plan, file and report to support ISO 14971-compliant risk documentation.

Editable templates for validation master plans, validation plans/reports and IQ/OQ/PQ protocols, including example OQ for injection molding and CSV checklists.

Templates and summary forms for managing corrective and preventive actions, including request forms and effectiveness checks.

Standardized template for managing design changes during medical device development.

Standardized template for creating design verification and validation plans.

Standardized template for documenting design verification and validation results.

Onsite and remote audits of your organization including internal audits, supplier audits, and mock inspections tailored to your needs.

Onsite or remote training covering standard medical device quality systems such as Design & Development, Equipment Qualification and Process Validation, CAPA, Risk Management, and MDSAP.

Professional freelancing and technical writing support for medical device businesses covering quality management systems, regulatory affairs, short-term firefighting activities, and long-term partnerships.

Consulting and training services for medical device safety risk management in accordance with ISO 14971, including templates and simplification methodologies.

Consulting and training services for medical device Corrective and Preventive Actions, including root cause investigation support and templates.

Consulting and training services for medical device manufacturing process validation, equipment qualification, computer system validation, and test method validation.

Training on requirements and preparation for MDSAP audits.

Seminars covering topics like MDR, MDSAP, Design Control, Process Validation, CAPA, Risk Management, Internal Audits, Technical Documentation, Labeling, Test Method Validation, and Vigilance.

Training on risk management and analysis for medical devices according to ISO 14971:2019.

Consulting services focused on medical device product development, simplifying design control processes, and linking them with risk management and quality engineering tools.

Training on implementing and managing CAPA systems for medical devices.

English language training on process validation for medical devices.

Training on process validation principles within medical device manufacturing.

Trainings and webinars including MDSAP NC grading system, internal auditor qualification, DHF management, and ISO 13485.

Training course covering quality management systems according to ISO 13485.

Training on design control requirements for medical devices.

Training on supplier management and auditing for medical devices.

Practical implementation and transfer of process validation concepts.

Training program for conducting internal quality audits.

Training on technical documentation preparation according to MDR.

Training on test method validation during the development and manufacturing of medical devices.

Training on benefit-risk analysis for medical devices.

Training on biological evaluation of medical devices.

Ein eintägiger Lehrgang zur Nutzen-Risiko-Analyse als Herzstück der Konformitätsbewertung unter der MDR 2017/745 in Verbindung mit ISO 14971 und der klinischen Bewertung.

Detailed training on the European Medical Device Regulation.

Training on standards-compliant and safe medical device labeling.

Standardized template for organizing the Design History File table of contents.

Training on vigilance requirements for medical device manufacturers under the MDR.

Standardized template for structuring the Device Master Record.

Training program for medical technology specialists.

Quality management training program in cooperation with IHK Reutlingen.

A short, hands-on 90-minute webtraining focusing on statistical sampling plans and handling of non-normal data.