November 19, 2009

Worldwide market clearance of medtech stand-alone and embedded software is increasingly complex, and the challenges to Regulatory Affairs professionals can be overwhelming.

Ever-changing standards, localization, V&V, IQ/OQ/PQ, security, privacy, and documentation requirements are complicated by outsourcing trends, evolutions of the operating systems and platforms, and the cryptic nature of the software code.

How can you be confident that your submission is complete, readily reviewable, and easily supported? How might you best maintain active market clearance in a context of continuous software updates and frequent major releases?

Join clinivation Vice President Richard Morroney, RAC, CQA, and clinivation partner IBM and Mr. Paul Urban, IBM Senior Manager, Medical Device Systems Modeling.

Together they will present the latest best practices for development, V&V, and market clearance of medtech software in the major world markets. Approaches to clarify submission content, facilitate more efficient regulatory reviews, and accelerate approval cycles will be discussed.

October 29, 2009

Learn about the requirements for achieving market clearance in selected Latin American countries. Discuss registration processes, submission requirements, and harmonization activities in Venezuela.

August 27, 2009

Learn about the requirements for achieving market clearance in selected Latin American countries. Discuss registration processes, submission requirements, and harmonization activities in Colombia.

June 25, 2009

Learn about the important changes in the Medical Device regulations and market clearance requirements. Review current submission procedures, registration requirements, and more.

April 30, 2009

Learn about the recent changes in medical device market clearance requirements in the Asia-Pacific countries. Review changes to regulations and recent harmonization initiatives, and discuss the industry best practices for complying with the constantly changing requirements.

March 26, 2009

Learn about the requirements for achieving market clearance in India. Discuss the registration process, submission requirements, and more.

February 26, 2009

Learn about the recent changes to the European Union’s medical device regulations. Review and discuss the amendments to the Medical Device Directive, to the Active Implantable Medical Device Directive, and more.

January 29, 2009

Learn about the new requirements for achieving market clearance in Italy. Review and discuss the requirements and the industry best practices for registering medical devices in the Italian MOH’s Medical Devices Database.

December 11, 2008

Learn about the important changes in the Medical Device regulations and market clearance requirements. Review current submission procedures, registration requirements, and more.

October 30, 2008

Learn how the Ministry of Health and Social Development of the Russian Federation regulates medical devices. Discuss best practices to obtain market clearance including product classification, standards, and other requirements. Participate in an informative Q&A dialogue after the presentation. Seminar length is approximately 45 minutes followed by a 15 minute Q&A session.

August 28, 2008

Learn how industry leaders prioritize regulatory activities, leverage core competencies against real opportunities, create sustainable competitive advantage, and formulate and implement robust global market clearance strategy.

July 31, 2008

Learn how corporate governance gets blindsided by the myriad compliance risks, far-reaching decision-making, and information silos intrinsic to global market clearance operations. Discuss benchmarking your company with a Market Clearance Compliance Maturity Model that measures visibility on operations, organizational and business controls, process standardization and automation, and value-added infrastructure.

June 26, 2008

Learn about key market clearance regulations for medical devices and diagnostic equipment in Brazil. Discuss import/export regulations, clinical trial requirements and guidance, and the pending establishment of a National Health Surveillance System for post-market surveillance. Participate in an informative Q&A dialogue after the presentation. Seminar length is approximately 45 minutes followed by a 15 minute Q&A session.

April 24, 2008

Learn about the key market clearance regulations for medical device & diagnostic companies. Discuss import/export regulations, the consequences of non-compliance, and the cost of improperly-managed market clearance operations.

February 28, 2008

Learn about advertising and labeling your medical device in Australia. Discuss industry best practices, guidelines, and what to expect when marketing your product.

December 13, 2007

Learn the basics - plus more - about advertising your medical device in the major world markets. Discuss the distinction between ad and promo activities, versus marketing activities that that are mainly intended to disseminate institutional messages or convey health promotion and disease prevention awareness.

October 25, 2007

Learn the basics - plus more - about advertising your medical device in the major world markets. Discuss industry best practices, guidelines, and what to expect when marketing your product.

August 30, 2007

Learn how the FDA is working to implement a device tracking system to improve patient safety. Discuss the benefits and costs associated with the development, identification, and use of a UDI system and the use of various automatic identification technologies.

June 28, 2007

Learn about the recent revisions to ISO 14971 and the Risk Management Best Practices specific to medical devices manufacturers. Discuss how to incorporate a robust risk assessment early in the design specification process to identify risk mitigations and the verification methods necessary for assuring product safety and much more.

April 26, 2007

Learn about recent updates of IEC 60601 and their impact on regulatory submissions and approvals for medical equipment in various countries. Also included are tips on how to prepare your medical device for laboratory testing.

February 16, 2007

Learn about the key aspects of the new China RoHS (Restriction of Hazardous Substance) regulation which provides a broad regulatory framework for a variety of products and parts. Discuss substance restrictions, pre-market certifications, labeling, and information disclosure requirements as they relate to medical devices and other products.

December 07, 2006

Learn about the key aspects of the standards requirements and their impact on regulatory submissions and approvals for medical equipment in various countries. Also included are tips on how to prepare your medical device for laboratory testing.

October 26, 2006

Learn about the recent changes in the Medical Device Evaluation Center of China's State Drug Administration. Review current submission procedures, registration requirements, and more.

September 28, 2006

Learn about the recent changes in the Asia Pacific countries including regional harmonization efforts. Review changes to regulations, recent harmonization initiatives, and how to succeed during this period of constant change.

August 31, 2006

Learn about the proposed National Device Regulation planned to be implemented by 2007 by the Malaysian Ministry of Health. Discuss MeDVER – Malaysia’s volunteer registration for medical device establishments – product classifications, registration requirements, and more.

July 27, 2006

Learn about the necessary in-country review (ICR) process of translated documents that accompany a device submission in foreign countries. Discuss the ICR process, the different ICR options, and more.

June 29, 2006

Learn how the Ministry of Health of the Russian Federation governs the registration of medical devices. Discuss product classifications, registration requirements, and more.

May 25, 2006

Learn about recent developments regarding the Global Harmonization Task Force Study Group 2's mission of comparing the adverse event reporting, post-market surveillance and other forms of vigilance for medical devices throughout the world to find suitable elements for harmonization. Discuss proposed documents pending review, electronic reporting, adverse event coding, and more.

April 27, 2006

Learn what's new with the FDA STED initiative including the recent extension of the pilot program. Discuss the initiative's progress, status, milestones, and timelines.

March 23, 2006

Learn about the latest changes in Korea's Medical Device Act and how these changes will affect new and already approved products. Discuss product classifications, technical file requirements, and more.

February 23, 2006

Learn about the Health Products Act proposed by Singapore’s Health Sciences Authority to combine the current laws governing medical devices. Discuss product classifications, registration requirements, and more.

January 25, 2006

Learn about recent developments regarding the Global Harmonization Task Force Study Group 1's mission of comparing the medical device regulatory systems throughout the world to find suitable elements for harmonization. Discuss two proposed documents pending review that address the classification and the conformity assessments of medical devices.

December 01, 2005

Learn how to navigate through the Indian medical device registration process. Discuss the registration requirements, product classifications, and more.

October 27, 2005

Learn about the international regulations governing medical device recalls in the major world markets. Discuss physician and consumer notification requirements, FDA requirements, implications for distributors, and more.

September 22, 2005

Learn more about what it takes to develop effective, compliant medical device labeling for the EU. Discuss standards, directives, compliance requirements, and more.

August 18, 2005

Learn what's new with harmonized adverse event coding for medical device approvals, compliance, and post-marketing commitments. Discuss the emergence of MedDRA, the changing regulatory environment, approaches to process automation, and more.

June 30, 2005

Learn how to navigate through the Australian medical device registration process. Discuss the Therapeutic Goods Act, product classifications, registration requirements and more.

May 26, 2005

Learn what's new with the FDA STED initiative including the recent extension of the pilot program. Discuss the initiative's progress, status, milestones, and timelines.

April 28, 2005

Learn about the latest changes in Korea's New Medical Device Act and how these changes will affect new and already approved products. Discuss product classifications, technical file requirements, and more.

March 31, 2005

Learn about the FDA and customs requirements for importing and exporting medical devices in the US. Discuss documentation, labeling requirements and more.

March 03, 2005

Learn how to incorporate a robust risk assessment early in the design specification process to identify risk mitigations and the verification methods necessary for assuring product safety. Discuss the responsibilities of the manufacturer, safety testing, and more.

January 20, 2005

Learn how to navigate through the Korean medical device registration process. Discuss product and enterprise registration certificates, product classifications, labeling, and more.

December 01, 2004

Learn how kits, accessories, and companion products are registered in the major world markets. Discuss the policies, paperwork, and how to manage the permutations of product approvals.

October 28, 2004

Learn what is needed to import and export medical devices around the world. Discuss documentation, labeling requirements, and more.

September 30, 2004

Learn how new, high risk Class III/IV medical devices are regulated in North America and the EU. Discuss device classification and various approval pathways and timelines.

August 26, 2004

Learn what it takes to ensure that your device labeling meets global requirements. Discuss the labeling requirements and recent harmonization initiatives for North America, EU, Asia, and other regions.

July 29, 2004

Learn how Mexico's Secretariat of Health (Salud) and the Mexican Institute of Social Security approve and regulate medical devices. Discuss current best practices, recent harmonization initiatives, and registration requirements for purchases made by the governments.

July 01, 2004

Learn what's new with the FDA STED initiative as it approaches its key pilot program milestone. Discuss the initiative's progress, status, and timelines.

May 27, 2004

Learn how Brazil's National Health Vigilance Agency, Argentina's National Administration of Drugs, Foodstuffs, and Medical Technology, and Peru's Ministry of Health approve and regulate medical devices. Discuss current best practices, recent harmonization initiatives, and registration requirements for purchases made by the governments.

April 29, 2004

Learn how to navigate through the Medical Device Evaluation Center of China's State Drug Administration. Discuss product and enterprise registration certificates, product classifications, quality system certifications and declarations, and more.

March 25, 2004

Learn what it will take for your next Canadian submission to clear the hurdles and achieve approval. Review some recent benchmark approvals that illustrate the latest approaches to product classification, panel reviews, approval forecasting, and more.

February 26, 2004

Learn what you must do to keep your registration, development, and production operations in compliance with the latest international standards. Review recent evolutions of the key international quality, risk management, and product safety standards.

January 15, 2004

Learn the basics - plus more - about submissions and registrations in the major world markets. Review the procedures, paperwork, and what to expect after submission.

December 11, 2003

Learn how many Pacific Rim countries are attempting regional harmonization. Review current submission procedures, recent harmonization initiatives, and how to succeed during this period of constant change.

November 20, 2003

Learn how the FDA is working to harmonize device submissions worldwide. Review the initiative's goals, pilot activities, and timeline.