• What are the differences between the old Directives and the new Regulations for medical technology?
• What is really changing and what do you need to know?

Listen to strategic and tactical actions your company can implement now to ensure alignment with the New EU Regulations.

Have your questions answered by Paul Brooks, VP of Healthcare Solutions at BSI, and interact with conference attendees during this table discussion

Dr. Jeff Shuren, Director of CDRH, will share the Agency’s vision and strategy for implementing the FDA Safety and Innovation Act requirements, as well as anticipated challenges. Dr. Shuren will address the audience via remote presentation.

• Unique Device Identification
• 510(k) Submissions
• Inspection Readiness
• Design Controls
• Supplier Qualification

Hear directly from FDA Leadership on the impact of the number one strategic priority for the Office of Compliance.  How will this initiative impact you, what are the anticipated changes, and what is the implementation plan.

Update and discussion on non-fee related provisions of FDASIA.  This session will discuss additional requirements and expectations for the FDA, guidance related constraints on the Agency, and relief for the industry.

Learn what’s happening as we await publication of the final UDI rule.  Understand how labeling, direct part marking and the new UDI Database will come together.  Ask questions on what you should be doing regarding implementation.

Participants will work at their tables on the top priorities for their “Act – Change – Transfer” forms.

FDA Leadership from the Office of Device Evaluation will share their top priorities and strategic direction, as well as anticipated challenges.

FDA overview on Total Product Life Cycle and discussion of the TPLC database – a case study on post-market surveillance and interdependencies with risk management, CAPA and design.

Haunted by Your Words: How to Avoid Mistakes that Destroy Your Credibility

Group activity and discussion around some of the critical components of the Total Product Life Cycle based on a case study.  Explore the continuous Total Product Life Cycle from Post-Market Surveillance through CAPA and back to Design, including the interdependency of Risk Analysis throughout the cycle.

FDA recently announced its new Pre-submission program. This session will focus on how the Pre-Submission program operates within FDA’s existing IDE, PMA, HDE, 510(k) and de novo regulatory pathways. The speaker will discuss MDUFMA III changes to the pre-submission processes and how the pre-submission program can help medical device manufacturers identify and understand the regulatory requirements earlier in the device development lifecycle will.

Industry has ongoing concerns that the 510(k) review process continues to delay approvals and stifle innovation. This session will discuss FDA’s recently released refusal to file guidance and common quality issues with 510(k) submissions. The discussion will include FDA performance metrics under the current regulations and changes implemented with MDUFMA III.  An industry perspective will be presented using representative case studies.

Group Activities and Discussion around some of the critical components of the Total Product Life Cycle based on a Case Study.

Explore the continuous Total Product Life Cycle from Post-Market Surveillance through CAPA and back to Design, including the interdependency of Risk Analysis throughout the cycle.

The FDA recently issued several new guidances and draft guidances as part of its MDUFMA III initiatives. This session will provide insight on FDA’s new eCopy program, FDA’s criteria for acceptance reviews of 510(k)’s, criteria for acceptance and filing reviews of PMA’s, and MDUFMA III performance requirements. The effects of MDUFMA III on postmarket initiatives, device classification and reclassification, and the de novo pathway will also be discussed.

Attendees of this session will hear from a panel of experts on this hot and evolving topic, including discussion of the following:

• When is software or an app a device, and when is it not a device?
• What are the expectations from the Agency?
• Discussion of HIPPA, Validation and common standards for Electronic Medical Records.

Join us in this timely session as we hear directly from key members of OCP management on the current regulatory environment for combination products, what to expect from OCP in 2013 and beyond, and especially, their pointers for industry regarding ‘what works and what doesn’t ‘ for manufacturers seeking FDA approval of combination products.

In addition to these presentations, much of this session will be designed to provide an opportunity for industry representatives and audience participants to interact directly with OCP staff to ask questions and get input on questions related to combination product approvals and regulation.

Compliance with the Medical Device Directives is essential to gaining a CE Mark and access to the European Market. This session will identify the steps required to reduce the risks and uncertainty in the EU regulatory process and thus bring products to the EU market more quickly. Discussion topics will include the legal and operational aspects of European CE Marking, the structure and purpose of the Medical Device Directives, format and use of technical documents, and conducting internal and external audits.

Notified Bodies will be asking questions in upcoming audits and reviews to ensure manufacturers who place devices on the market in Europe are aware of the gaps between the requirements of the ISO 14971 and the Directives. Some of the content deviations described in Annex Z of EN ISO 14971:2012 will be discussed – have risks have been reduced as much as possible, have appropriate controls been used and are all residual risks acceptable in light of state of the art.

Congressman Erik Paulsen will provide his perspective from Capitol Hill on changes that have impacted our industry, changes to come, and the challenges that lie ahead. Plan to join us for this insightful and memorable evening.

A well-crafted global product strategy prioritizes potential opportunities and takes calculated risks to ensure success. A robust clinical strategy for the company’s pipeline products that begins in the early device development stage and extends after product launch in order to drive market share and extend product life is an important element of the global product strategy. An industry representative will discuss the effect of emerging markets and the changing regulatory landscape of the major market sectors on global product strategy. The presenter will discuss real-life working experiences in developing a comprehensive global product strategy and transforming regulatory information into actionable regulatory intelligence that drives development and differentiates market share.

Position your company for successful registration in one of the fastest growing markets in the world.  In this presentation, hear from experts on practices of common acceptance for registration of medical products in Central and South America.

Hear what the FDA is looking for during inspection directly from FDA Officers and Field Investigators. FDA Field Investigators will share examples with participants. This session will focus on the main deficiencies found in each subsystem and post-inspection activities.

Participants will turn the top priorities they have captured on their “Act – Change – Transfer” forms into an Action Plan.

Tom Meyer