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SMI Solution // Medical Device Regulatory and Quality Consulting // SMI Solutions

Are you introducing a new medical device to market? Having trouble with ISO certification? Welcome to SMI Solutions. SMI-Solutions provides global medical device regulatory and quality consulting. We can help you access the fastest growing device markets worldwide. Our services include:. Medical device regulatory strategy. Medical device registration and approval. Medical Device Establishment licence registration. Medical device reporting requirements. Let experience clear your path to market. European P...

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SMI Solution // Medical Device Regulatory and Quality Consulting // SMI Solutions | smi-solutions.com Reviews

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Are you introducing a new medical device to market? Having trouble with ISO certification? Welcome to SMI Solutions. SMI-Solutions provides global medical device regulatory and quality consulting. We can help you access the fastest growing device markets worldwide. Our services include:. Medical device regulatory strategy. Medical device registration and approval. Medical Device Establishment licence registration. Medical device reporting requirements. Let experience clear your path to market. European P...

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SMI Solution // Medical Device Regulatory and Quality Consulting // SMI Solutions | smi-solutions.com Reviews

https://smi-solutions.com

Are you introducing a new medical device to market? Having trouble with ISO certification? Welcome to SMI Solutions. SMI-Solutions provides global medical device regulatory and quality consulting. We can help you access the fastest growing device markets worldwide. Our services include:. Medical device regulatory strategy. Medical device registration and approval. Medical Device Establishment licence registration. Medical device reporting requirements. Let experience clear your path to market. European P...

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smi-solutions.com

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Medical Device News // ISO Training – What is CE Certification // SMI Solutions

http://www.smi-solutions.com/news

You are here: Home. Effective and Efficient FDA Audit Preparation. Preparing for FDA audits can be demanding on a company’s resources. By examining how audits are performed and common Form 483 citations published on the FDA website. FDA audit priorities can be identified and resources can be better targeted. The FDA published a helpful guidance document called Guide To Inspection of Quality Systems. Which outlines a common approach taken by FDA inspectors in conducting audits. An audit will generally sta...

2

MedWatcher Mobile App for FDA Medical Device Vigilance - SMI Solution

http://www.smi-solutions.com/medwatcher-mobile-app-for-fda-medical-device-vigilance

You are here: Home. MedWatcher Mobile App for FDA Medical Device Vigilance. MedWatcher Mobile App for FDA Medical Device Vigilance. Unfortunately there is no such app for medical device manufacturers and facilities for mandatory or voluntary reporting, however, it represents a positive step in direction of ease of reporting, and data collection for the FDA. Read the whole announcement from FDA here. Feature image by philcampbell. On August 13, 2013, posted in:. Mail (will not be published) (required).

3

Quality Assurance // Validation and Verification – Medical Device Development // SMI Solutions

http://www.smi-solutions.com/quality-consulting-services

You are here: Home. Quality Management System Gap Analysis and Internal Audit Support. Quality Manual and Documentation development. Training including GMP training. Implementation and development of processes and procedures. Validation and Verification protocol development. Don’t see what you are looking for? To see how we help you with your quality compliance. Southmedic Inc has been ISO certified since 1996 and has since expanded their quality management system to comply with global markets.

4

Regulatory Services // Product Registration – Path to Market – Medical Device Reporting // SMI Solutions

http://www.smi-solutions.com/quality-consulting-services/regulatory-consulting-services

You are here: Home. Medical device registration and approval. Post market surveillance support. Label compliance for global marketing. Global regulatory strategic planning. Don’t see what you are looking for? To see how we help you with your regulatory compliance. Let experience clear your path to market. December 4, 2013. Effective and Efficient FDA Audit Preparation read more. October 23, 2013. Medical Device Reform in the European Union read more. September 26, 2013. August 13, 2013. August 7, 2013.

5

Effective and Efficient FDA Audit Preparation - SMI Solution

http://www.smi-solutions.com/hot-topics-in-fda-audits

You are here: Home. Effective and Efficient FDA Audit Preparation. Effective and Efficient FDA Audit Preparation. Preparing for FDA audits can be demanding on a company’s resources. By examining how audits are performed and common Form 483 citations published on the FDA website. FDA audit priorities can be identified and resources can be better targeted. The FDA published a helpful guidance document called Guide To Inspection of Quality Systems. The 15 sections of the 21 CFR 820. An audit will generally ...

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SMI Solution // Medical Device Regulatory and Quality Consulting // SMI Solutions

Are you introducing a new medical device to market? Having trouble with ISO certification? Welcome to SMI Solutions. SMI-Solutions provides global medical device regulatory and quality consulting. We can help you access the fastest growing device markets worldwide. Our services include:. Medical device regulatory strategy. Medical device registration and approval. Medical Device Establishment licence registration. Medical device reporting requirements. Let experience clear your path to market. European P...

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