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Medisonos Medical Device Consulting

Consulting Project Management Medical Device Health Care Regulatory Quality Management Systems Complaint Handling CAPA Warning Letter Process Validation Vigilance Design Validation 510k CE mark 483 FDA

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Consulting Project Management Medical Device Health Care Regulatory Quality Management Systems Complaint Handling CAPA Warning Letter Process Validation Vigilance Design Validation 510k CE mark 483 FDA
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Medisonos Medical Device Consulting | medisonos.com Reviews

https://medisonos.com

Consulting Project Management Medical Device Health Care Regulatory Quality Management Systems Complaint Handling CAPA Warning Letter Process Validation Vigilance Design Validation 510k CE mark 483 FDA

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1

Medisonos Medical Device Consulting

http://www.medisonos.com/validation.php

Validation of fully automated assembly process of disposables (Medical Device), automated. Validaiton of gluing process (Medical Device), automated. Validation of Buffer tank production (Pharma), semi-automated. Production (IVD), manual. Validation of IHC and Probe final tests kits for product release (IVD). Validation of various analytical methods (ELISA, Spectrophotometry, pH, conductivity, etc. Stabilize production processes to ensure repeatability and reproducibility. Validate according to 21CFR211&#...

2

Medisonos Medical Device Consulting

http://www.medisonos.com/index.php

We bring extra drive to your projects to. Reach goals on time and within budget. With. Experience in medical device development, documentation and registration,. We get the job done right. We have years of experience working for world-leading multinational organizations and know the importance of working within your process. We use a structured approach to ensure proper execution. By building and developing stong teams where people and skills fit together, we increase efficiency and output.

3

Medisonos Medical Device Consulting

http://www.medisonos.com/projects.php

Project leadership from identifying business needs to the successful registration and global launches of several medical devices (classes I, IIb and combination products) multiple projects. Identify customer needs from marketing and customer research with global partners. Explore concepts that meet customer expectations, business needs and technical boundaries. Perform feasibility studies and capture all input to minimize risk during development. Thorough project planning of tasks, gates and resources.

4

Medisonos Medical Device Consulting

http://www.medisonos.com/remediation.php

Lead turnaround of major IVD player from FDA warning letter to successful clearance of all findings. Re-certification of ISO 13485 after major findings across organization from notified body. Update risk management files after update to ISO 14971. Process validation to comply with GMP (2011) for statistical sample sizes. Set up and run CAPA process. Perform gap analysis across operations to ensure patient safety is maintained. Define and implement immediate actions to avoid further escalation. We analyze...

5

Medisonos Medical Device Consulting

http://www.medisonos.com/services.php

Concept generation and testing. Requirements engineering and traceability. Design verification at all product levels. Design validation / human factor engineering. We can step into any part of the development phase to help progress things, working alongside your team. 21CFR 820, GMP. Medical devices and combination products. Device history file and master record. Documentation for registration (CE and 510k). Quality system GAP analysis. Remediation work across products, project and QMS. A medical device ...

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Medisonos Medical Device Consulting

We bring extra drive to your projects to. Reach goals on time and within budget. With. Experience in medical device development, documentation and registration,. We get the job done right. We have years of experience working for world-leading multinational organizations and know the importance of working within your process. We use a structured approach to ensure proper execution. By building and developing stong teams where people and skills fit together, we increase efficiency and output.

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Code of Ethical Conduct. Medison is Israel’s leading international marketing group for innovative niche healthcare solutions. With three generations of experience, Medison is uniquely qualified to provide the complete spectrum of integrated services for international companies in the Israeli and Romanian healthcare markets.

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