Clinical Evaluation Report for Europe and MEDDEV Expectations: Impact with New Medical Device Regulations (MDR)

Clinical Evaluation Report for Europe and MEDDEV Expectations: Impact with New Medical Device Regulations (MDR)

“Course “”Clinical Evaluation Report for Europe and MEDDEV Expectations: Impact with New Medical Device Regulations (MDR)”” has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Overview:
Why you should attend
• Introduction to MEDDEV 2.7.1, Revision 4 (2016)
• This revised MEDDEV is generated within a context of increased scrutiny on the Notified Bodies (NB) by the Joint Assessments from the Competent Authorities, which has led to an increase in the level of review the NB exercise over clinical evaluations
• Frequency for updating the CER is also much more prescriptive now and you must define and justify the frequency, based on “”significant risk”” of the device, as well as how “”well-established””
• One of the largest changes in this revision, the demonstration of “”equivalence”” is much harder now
• Revision will lead to more clinical investigations, probably of larger size and notified bodies will be looking more closely at how all the essential requirements are met, including those regarding usability
• Manufacturers should start discussing with their notified bodies how they will start implementing these new requirements and to start performing their gap assessments and resource needs-assessments now
• General considerations on updating the clinical evaluation
• How is a clinical evaluation performed?
• Appraisal of pertinent data
• The role of the notified body in the assessment of clinical evaluation reports and key changes in 2016
• Implement risk evaluation pre/post review
• Establish design and intended use equivalence with competitor and preexisting designs
• Identify data available from the clinical literature
• Supply and prepare documentation relating to clinical investigations that meets Notified Body requirements (if clinical investigation was deemed necessary and completed)
• Demonstrate that there is sufficient clinical data to meet the safety and performance requirements of the device
• Identify residual clinical risks and determine whether post-market clinical follow-up is required
• Maintain and update clinical evaluation documentation throughout post-market product lifecycle
• The initial creation of a CER can be a painstakingly long process, and for smaller manufacturers, can prove quite burdensome – learn how to complete a literature review report which is a comprehensive analysis of available pre- and post-market clinical data relevant to the intended use of the device and includes clinical performance and safety data
• Learn how the new MDR for Europe has a direct impact on the CER going forward
• Why CERs need to be reassessed under the new MDR
• Learn how to plan for a gap assessment to transition an organization to compliance for your CER under Europe’s Medical Device Regulation 2017/745″

Corrective and Preventative Action Topics: Investigation Phase, Action Phase and Verification of Effectiveness Phase

Corrective and Preventative Action Topics: Investigation Phase, Action Phase and Verification of Effectiveness Phase

This two-day hands-on workshop utilizes a teach-do-teach-do approach that keeps participants engaged throughout the course.

Many real CAPA examples are presented. CAPA owners are often challenged with understanding how to utilize data analysis tools during the investigation phase.

This workshop explains when and how to apply many of the common analysis tools necessary to conduct effective CAPA investigations. Additionally, the course demonstrates methods to scope CAPAs and to develop robust CAPA verification of effectiveness plans utilizing risk-based sampling to ensure CAPA effectiveness is confirmed with a high degree of confidence.

The CAPA Workshop focuses on the three phases of CAPA: Investigation Phase, Action Phase and Verification of Effectiveness Phase.

A manufacturing case study is utilized where participants work in teams, following a problem-solving methodology, to identify root cause, brainstorm possible actions, and develop a verification of effectiveness plan. The workshop provides examples of how to document the various CAPA phases.

Good and poor examples are presented along the way. Participants find this particularly useful as a reference when documenting their own CAPAs.

This two-day hands-on workshop utilizes a teach-do-teach-do approach that keeps participants engaged throughout the course.

Many real CAPA examples are presented. CAPA owners are often challenged with understanding how to utilize data analysis tools during the investigation phase.

This workshop explains when and how to apply many of the common analysis tools necessary to conduct effective CAPA investigations. Additionally, the course demonstrates methods to scope CAPAs and to develop robust CAPA verification of effectiveness plans utilizing risk-based sampling to ensure CAPA effectiveness is confirmed with a high degree of confidence.

The CAPA Workshop focuses on the three phases of CAPA: Investigation Phase, Action Phase and Verification of Effectiveness Phase.

A manufacturing case study is utilized where participants work in teams, following a problem-solving methodology, to identify root cause, brainstorm possible actions, and develop a verification of effectiveness plan. The workshop provides examples of how to document the various CAPA phases.

Good and poor examples are presented along the way. Participants find this particularly useful as a reference when documenting their own CAPAs.

Supplier Management for Medical Device Manufacturers

Supplier Management for Medical Device Manufacturers

This course delivers the tools, templates, and methods to help participants implement an effective, efficient, and compliant supplier management program.

This two-day hands-on workshop provides a clear understanding of the underlying principles of supplier management, using exercises to help illustrate the points and solidify understanding. In addition, the course uses FDA Warning Letters to raise issues and help you learn from others.

As part of the practical implementation, the course includes supplier evaluation and selection; measuring, monitoring, and re-evaluation; outsourced processes; supplier auditing techniques; and supplier issues in management review.

This course delivers the tools, templates, and methods to help participants implement an effective, efficient, and compliant supplier management program.

This two-day hands-on workshop provides a clear understanding of the underlying principles of supplier management, using exercises to help illustrate the points and solidify understanding. In addition, the course uses FDA Warning Letters to raise issues and help you learn from others.

As part of the practical implementation, the course includes supplier evaluation and selection; measuring, monitoring, and re-evaluation; outsourced processes; supplier auditing techniques; and supplier issues in management review.

This course delivers the tools, templates, and methods to help participants implement an effective, efficient, and compliant supplier management program.

This two-day hands-on workshop provides a clear understanding of the underlying principles of supplier management, using exercises to help illustrate the points and solidify understanding. In addition, the course uses FDA Warning Letters to raise issues and help you learn from others.

As part of the practical implementation, the course includes supplier evaluation and selection; measuring, monitoring, and re-evaluation; outsourced processes; supplier auditing techniques; and supplier issues in management review.
This course delivers the tools, templates, and methods to help participants implement an effective, efficient, and compliant supplier management program.

This two-day hands-on workshop provides a clear understanding of the underlying principles of supplier management, using exercises to help illustrate the points and solidify understanding. In addition, the course uses FDA Warning Letters to raise issues and help you learn from others.

As part of the practical implementation, the course includes supplier evaluation and selection; measuring, monitoring, and re-evaluation; outsourced processes; supplier auditing techniques; and supplier issues in management review.

International Conference on Nursing Care 2018

International Conference on Nursing Care 2018

Nursing Care 2018 is a phase for nursing understudies, staff, senior individuals, investigators, and pioneers to cooperate on subjects influencing nursing instruction.

Nursing Care 2018 includes the speculative and sensible planning provided for Nurse Practitioners and the motivation to set them up for their commitments as nursing care experts.

Nursing Care 2018 is a phase for nursing understudies, staff, senior individuals, investigators, and pioneers to cooperate on subjects influencing nursing instruction.

Nursing Care 2018 includes the speculative and sensible planning provided for Nurse Practitioners and the motivation to set them up for their commitments as nursing care experts.

Nursing Care 2018 is a phase for nursing understudies, staff, senior individuals, investigators, and pioneers to cooperate on subjects influencing nursing instruction.

Nursing Care 2018 includes the speculative and sensible planning provided for Nurse Practitioners and the motivation to set them up for their commitments as nursing care experts.

Nursing Care 2018 is a phase for nursing understudies, staff, senior individuals, investigators, and pioneers to cooperate on subjects influencing nursing instruction.

Nursing Care 2018 includes the speculative and sensible planning provided for Nurse Practitioners and the motivation to set them up for their commitments as nursing care experts.

Nursing Care 2018 is a phase for nursing understudies, staff, senior individuals, investigators, and pioneers to cooperate on subjects influencing nursing instruction.

Nursing Care 2018 includes the speculative and sensible planning provided for Nurse Practitioners and the motivation to set them up for their commitments as nursing care experts.

Nursing Care 2018 is a phase for nursing understudies, staff, senior individuals, investigators, and pioneers to cooperate on subjects influencing nursing instruction.

Nursing Care 2018 includes the speculative and sensible planning provided for Nurse Practitioners and the motivation to set them up for their commitments as nursing care experts.

Nursing Care 2018 is a phase for nursing understudies, staff, senior individuals, investigators, and pioneers to cooperate on subjects influencing nursing instruction.

Nursing Care 2018 includes the speculative and sensible planning provided for Nurse Practitioners and the motivation to set them up for their commitments as nursing care experts.

Sixth Annual Clinical Congress & AACE Gulf Chapter Meeting

Sixth Annual Clinical Congress & AACE Gulf Chapter Meeting

Sixth Annual Clinical Congress to be held in Intercontinental Hotel Dubai UAE November 1-3, 2018 is the largest endocrine and diabetes congress in the MENA region.

An interesting three-day program is designed to deliver a high-level scientific content with 8 states of the art lectures/plenary sessions, oral and poster presentations, a clinical debate and an endocrine grand round, 9 clinical practice symposia and 14 “meet the expert” sessions.

These sessions provide updates and state-of-the-art presentations delivered by renowned international and regional speakers.

Target Audience:
Endocrinologists & Diabetologists
Pediatricians
Family Medicine Physicians & Internists
Primary Care Doctors
Clinical Pharmacists
Dietitians
Hospitalists
Gynecologists
Nurses & Medical Students

Sixth Annual Clinical Congress to be held in Intercontinental Hotel Dubai UAE November 1-3, 2018 is the largest endocrine and diabetes congress in the MENA region.

An interesting three-day program is designed to deliver a high-level scientific content with 8 states of the art lectures/plenary sessions, oral and poster presentations, a clinical debate and an endocrine grand round, 9 clinical practice symposia and 14 “meet the expert” sessions.

These sessions provide updates and state-of-the-art presentations delivered by renowned international and regional speakers.

Target Audience:
Endocrinologists & Diabetologists
Pediatricians
Family Medicine Physicians & Internists
Primary Care Doctors
Clinical Pharmacists
Dietitians
Hospitalists
Gynecologists
Nurses & Medical Students

Sixth Annual Clinical Congress to be held in Intercontinental Hotel Dubai UAE November 1-3, 2018 is the largest endocrine and diabetes congress in the MENA region.

An interesting three-day program is designed to deliver a high-level scientific content with 8 states of the art lectures/plenary sessions, oral and poster presentations, a clinical debate and an endocrine grand round, 9 clinical practice symposia and 14 “meet the expert” sessions.

These sessions provide updates and state-of-the-art presentations delivered by renowned international and regional speakers.

Target Audience:
Endocrinologists & Diabetologists
Pediatricians
Family Medicine Physicians & Internists
Primary Care Doctors
Clinical Pharmacists
Dietitians
Hospitalists
Gynecologists
Nurses & Medical Students

Diabetes R&D: Annual Diabetes Congress

Diabetes R&D: Annual Diabetes Congress

This Diabetes Research & Development meeting will give the concentrated learning on the circulation of information; chances to arrange and talk about science and drug on diabetes and medicinal services and the current advances and innovations related Diabetes for the improving of wellbeing.

New personalities will have the chance to investigate more subject matters on Diabetes Meeting.

With individuals from all around the globe expanding the information about Diabetes and Healthcare and the expansion in the new progress identified with Diabetes, this is your most obvious opportunity to achieve the biggest get-together of members.
This Diabetes Research & Development meeting will give the concentrated learning on the circulation of information; chances to arrange and talk about science and drug on diabetes and medicinal services and the current advances and innovations related Diabetes for the improving of wellbeing.

New personalities will have the chance to investigate more subject matters on Diabetes Meeting.

With individuals from all around the globe expanding the information about Diabetes and Healthcare and the expansion in the new progress identified with Diabetes, this is your most obvious opportunity to achieve the biggest get-together of members.
This Diabetes Research & Development meeting will give the concentrated learning on the circulation of information; chances to arrange and talk about science and drug on diabetes and medicinal services and the current advances and innovations related Diabetes for the improving of wellbeing.

New personalities will have the chance to investigate more subject matters on Diabetes Meeting.

With individuals from all around the globe expanding the information about Diabetes and Healthcare and the expansion in the new progress identified with Diabetes, this is your most obvious opportunity to achieve the biggest get-together of members.

New personalities will have the chance to investigate more subject matters on Diabetes Meeting.

With individuals from all around the globe expanding the information about Diabetes and Healthcare and the expansion in the new progress identified with Diabetes, this is your most obvious opportunity to achieve the biggest get-together of members.

International Healthcare Simulation Conference 2018

International Healthcare Simulation Conference 2018

International Healthcare Simulation Conference 2018 which is going to be held on October 22-23, 2018 in London, UK by Meeting International.

International Healthcare Simulation Conference 2018 based on the theme Simulating Healthcare and Its Utilization across the World.

The conference International Healthcare Simulation Conference will be focused on Simulation of Simulating Healthcare and Its Utilization across the World.

It will enhance in the field of medicine, healthcare, medical. Healthcare Simulation Conference focused on the theme Simulating Healthcare and its utilization across the world.

Healthcare research provides important information about disease trends and risk factors, outcomes of treatment or public health interventions, functional abilities, patterns of care, and healthcare costs and use.

International Healthcare Simulation Conference 2018 which is going to be held on October 22-23, 2018 in London, UK by Meeting International.

International Healthcare Simulation Conference 2018 based on the theme Simulating Healthcare and Its Utilization across the World.

The conference International Healthcare Simulation Conference will be focused on Simulation of Simulating Healthcare and Its Utilization across the World.

It will enhance in the field of medicine, healthcare, medical. Healthcare Simulation Conference focused on the theme Simulating Healthcare and its utilization across the world.

Healthcare research provides important information about disease trends and risk factors, outcomes of treatment or public health interventions, functional abilities, patterns of care, and healthcare costs and use.

International Healthcare Simulation Conference 2018 which is going to be held on October 22-23, 2018 in London, UK by Meeting International.

International Healthcare Simulation Conference 2018 based on the theme Simulating Healthcare and Its Utilization across the World.

The conference International Healthcare Simulation Conference will be focused on Simulation of Simulating Healthcare and Its Utilization across the World.

It will enhance in the field of medicine, healthcare, medical. Healthcare Simulation Conference focused on the theme Simulating Healthcare and its utilization across the world.

Healthcare research provides important information about disease trends and risk factors, outcomes of treatment or public health interventions, functional abilities, patterns of care, and healthcare costs and use.

25th World Nursing and Nurse Practitioner Conference

25th World Nursing and Nurse Practitioner Conference

Nurse Practitioner 2018 provides the perfect platform for just this as an interactive and engaging 2-day event: unique in format, content, networking, and engagement.

The event brings together truly innovative thinkers who are leading the way through trialing new disruptive solutions and rethinking the Nursing and Nurse Practice mindset and will help you to better understand how to develop the right Nurse Practice and strategy with a strong scientific, clinical and commercial mindset and how innovative scientific techniques, emerging technologies, and innovative devices can transform Nursing and Nursing Practitioner.
Nurse Practitioner 2018 provides the perfect platform for just this as an interactive and engaging 2-day event: unique in format, content, networking, and engagement.

The event brings together truly innovative thinkers who are leading the way through trialing new disruptive solutions and rethinking the Nursing and Nurse Practice mindset and will help you to better understand how to develop the right Nurse Practice and strategy with a strong scientific, clinical and commercial mindset and how innovative scientific techniques, emerging technologies, and innovative devices can transform Nursing and Nursing Practitioner.
Nurse Practitioner 2018 provides the perfect platform for just this as an interactive and engaging 2-day event: unique in format, content, networking, and engagement.

The event brings together truly innovative thinkers who are leading the way through trialing new disruptive solutions and rethinking the Nursing and Nurse Practice mindset and will help you to better understand how to develop the right Nurse Practice and strategy with a strong scientific, clinical and commercial mindset and how innovative scientific techniques, emerging technologies, and innovative devices can transform Nursing and Nursing Practitioner.
Nurse Practitioner 2018 provides the perfect platform for just this as an interactive and engaging 2-day event: unique in format, content, networking, and engagement.

The event brings together truly innovative thinkers who are leading the way through trialing new disruptive solutions and rethinking the Nursing and Nurse Practice mindset and will help you to better understand how to develop the right Nurse Practice and strategy with a strong scientific, clinical and commercial mindset and how innovative scientific techniques, emerging technologies, and innovative devices can transform Nursing and Nursing Practitioner.

Managing Your Complaints and Obstacles in Post-Market Requirements — Results from Top Medical Device Observations During an Inspection

Managing Your Complaints and Obstacles in Post-Market Requirements — Results from Top Medical Device Observations During an Inspection

Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time-consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.

By attending this seminar, you will discover:

How to overcome one of the biggest obstacles device manufacturers face
How the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentation
How and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall.
How to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, the expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real-life experiences of FDA.
Post-Market activities, Complaint Handling, MDRs, and Recalls are expensive, time-consuming, and often lead to more serious financial consequences. Over 80% of FDA Inspection target observations for lack of compliance in these areas.

By attending this seminar, you will discover:

How to overcome one of the biggest obstacles device manufacturers face
How the FDA expects you to develop and implement proper handling of complaints reportable or non-reportable, product complaint handling and documentation
How and when to file Medical Device Reports (MDR), effective and appropriate communication with the appropriate regulatory agencies in the event of a recall.
How to conduct a correction and removal actions to avoid a recall crisis, including required recordkeeping, the expectation from FDA and other regulatory agencies in the event of a recall and key factors in implementing and maintaining compliance with the regulations and real-life experiences of FDA.