Regulations and Guidelines
Showing 17–32 of 133 results
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WHO Draft: Global Model Regulatory Framework for Medical Devices including IVDs, 7/16
This 2016 draft document is intended to provide guidance to WHO Member States in developing and implementing regulatory controls relating to medical devices.
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FDA Draft Guidance: Dissemination of Patient-Specific Information from Devices, 6/16
June 2016 Draft Guidance intended to clarify that manufacturers may share patient-specific information from medical devices with patients.
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WHO Annex 5 Guidance on Good Data and Record Management Practices, 2016
This 2016 WHO Guidance outlines expectations for achieving data and record integrity, reliability, access-ability, and protection.
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OECD The Application of GLP Principles to Computerised Systems, 4/16
2016 OECD publication of standards for laboratory computer systems used in clinical studies destined for regulatory submissions.
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FDA Draft Guidance: Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices, 1/16
The 2016 FDA Guidance on Design Considerations and Recommendations for Interoperable Medical Devices promotes safe, effective data exchange between devices.
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FDA Draft Guidance: Manufacturing Site Change Supplements, 10/15
This 2015 DRAFT guidance is meant to help firms manage the timeframes for changes in manufacturing sites, processes, methods, procedures, qualifications, & validations.
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Eudralex V4 Annex 16: Certification by a Qualified Person and Batch Release, 10/15
EudraLex Volume 4, Annex 16 specifically allows for the use of validated computerized systems as safeguards to ensure that uncertified batches are not sold.
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FDA Guidance: Analytical Procedures and Methods Validation for Drugs and Biologics, 07/15
FDA recommendations on analytical procedures and methods validation to support the identity, strength, quality, purity, and potency of drug substances and drug products.
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EMA E6(R2): Guideline for Good Clinical Practice, 7/15
July, 2015 consensus draft of ICH E6(R2) for consultation. E6(R2) contains updated GCP requirements for system validation, audit trails, security, and quality assurance SOPs.
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ICH E6(R2): Good Clinical Practice, 6/15
June, 2015, ICH consensus draft for consultation. E6(R2) contains updated GCP requirements for system validation, audit trails, security, and quality assurance SOPs.
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PIC/S PS/INF: Guide to GMP for Medicinal Products, Qualification and Validation – Annex 15, 4/15
Annex 15 now refers readers to Annex 11, Computerised Sytems, for the specific details regarding validation of computer systems.
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Eudralex V4 Annex 15: GMP Guidelines for Qualification and Validation, 3/15
EudraLex Volume 4, Annex 15 now refers users to Annex 11, Computerised Systems, for the specific details regarding validation of computer systems.
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EC Guidelines on Good Distribution Practice for Active Substances, 3/15
In March, 2015 the EU Commission published GDP Guidelines for APIs. Details for electronic records, systems, and signatures are found throughout.
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FDA Presentation: Mobile Medical Apps, MDDS, General Wellness Apps, 2/15
FDA presentation to clarify guidance documents for Mobile Medical Applications, General Wellness Applications, and Medical Device Data Systems.
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FDA Guidance: Mobile Medical Apps, 2/15
This February 2015 FDA guidance provides information about how the agency intends to apply its regulatory authority to software applications on mobile platforms.
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FDA Guidance: Medical Device Data Systems, Image Storage Devices, and Image Communications Devices, 2/15
In February, 2015, the FDA published this guidance to inform that they does not intend to enforce compliance with the regulatory controls for Medical Device Data Systems.
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