Contact us

Design Controls for Medical Devices and IVDs

Dates

Times

2 days

Location

Virtual Learning

Availability

Dates

Times

2 days

Location

Virtual Learning

Availability

About This Course

This instructor-led two-day course covers design control principles and design and development regulatory requirements relative to U.S. 21 CFR Part 820, ISO 13485:2016 and the EU MDR. Practical examples will be incorporated.

This course covers important requirements for medical device and IVD design controls. Learners will benefit from open dialogue and the sharing of current design and development processes; highlighting how misperceptions of regulatory requirements have led to less-than-optimal practices. This course also provides guidance for all phases of medical device design and development projects, as well as retrospective gap analysis of design history files to help develop new technical files under the EU MDR and IVDR.

Key Learning Objectives

At the end of this training, learners will be able to:

  • Identify key regulatory requirements for risk management
    • European Union
    • Quality System Regulation
    • ISO 13485:2016
  • Identify key principles of ISO 14971:2019
  • Identify key regulatory requirements for design controls:
    • European Union
    • Quality System Regulation
    • ISO 13485:2016
  • Recognize potential exemptions from design control requirements
  • Identify when, during a design and development project, design control requirements apply
  • Conceptualize graphically a design control process

Who Should Attend

This class is vital for any medical device research and development professional, regulatory scientist and/or clinician involved in developing and manufacturing medical devices. This course provides critical knowledge for both regulatory affairs and quality assurance professionals.

Tutors

Course tutors selected from the following:

Robert Ruff - Rob has over 30 years’ experience in the medical device and public health sectors, including completing a long, distinguished career with the U.S. FDA. His extensive regulatory experience includes co-authoring the MDSAP Audit Model and the Quality System Inspection Technique (QSIT). He also developed FDA’s computer-based training for QSIT, the Quality System Regulation and the Medical Device Reporting Regulation.

Deborah Baker-Janis - Deborah Baker-Janis - Deborah joined NSF in 2013 after working in the medical device industry for over 10 years, including in both regulatory affairs and product development. Her experience includes the development of pre‐clinical testing protocols and reports, risk documentation, quality system and regulatory affairs standard operating procedures, sales training materials, safety reports and domestic and international regulatory strategies and submissions.

James Pink - James Pink has over 20 years of experience in the medical devices industry including 10 years as a health care technology expert and lead auditor for a leading European notified body. He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assurance programs for active and non-active implantable and combination products. Mr. Pink is a contributor to several medical device standards committees including ISO 13485, ISO 14971 and various product-related standards.

Janet Book - Janet Book has worked in the field of quality for the past 35 years in a wide variety of industries, including blood banking, food processing, quality consulting, chemical, pharmaceuticals and medical devices, she has conducted internal and supplier audits utilizing many different industry-specific standards, due diligence evaluations as well as capability assessments. She has been involved with writing quality procedures; developing supplier, internal and corporate audit programs; developing quality management systems; and developing and presenting quality-related training and seminars. Janet is a certified Six Sigma Black Belt and served as an adjunct professor at Carnegie Mellon University. Recently, she earned her Certificate in Privacy Law and Cyber Security and worked in privacy providing guidance on quality, regulatory and compliance functions. She is a senior member of the American Society for Quality (ASQ), an ASQ Certified Quality Auditor (CQA), an ASQ Certified Quality Engineer (CQE), an ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) and an RABQSA Quality Systems Lead Auditor.

Ashley Kelleher - Ashley has more than 14 years of professional experience in the medical device, pharmaceutical and certification industries. Her experience includes program management and project management of global, third-party, and notified body certifications for the medical industry. In addition, Ashley has expertise in reviewing technical file documentation (CE marking) and holds lead auditor certifications for ISO 13485, GDP, MDSAP, EU-MDR, ISO 14971, ISO 9001, and ISO 15378. Her educational background is in veterinary science.

  • Really liked the breakout rooms - helped to make it very interactive during these hard times.
    Annesa Seemungal
    Ascensia Diabetes Care
  • I was extremely impressed with the course participation and engagement by the group. This speaks highly to the instructors’ abilities to make it relevant to all participants. Both instructors provided excellent examples and took time to address all questions and keep things moving at the same time.
    Pam Schaub
    Ascensia Diabetes Care

Additional Recommended Courses

CAPA Considerations: Problem Statement Writing and Investigation Techniques

Utilizing proven methodologies, this highly interactive medical device CAPA writing course provides learners

with the tools and skills needed to identify root causes of existing nonconformities from complaints, process deviations, audits and other feedback mechanisms. 

This 2-day virtual instructor-led course covers how to effectively write concise, understandable problem statements and specific corrective action plans relative to problem statements. Learners are provided with instruction and guidance as they conduct hands-on medical device writing exercises, working through case studies of investigation data and summarizing key findings. Our highly experienced instructor will provide real-time feedback to help learners write concise medical device nonconformity statements.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Define the purpose of Corrective and Preventive Action (CAPA)
  • Identify and analyze data inputs for CAPA
  • Compose a proper and complete problem statement
  • Apply investigation techniques to identify root causes and define the appropriate corrective action
  • Identify effectiveness criteria and perform an effectiveness check
  • Recognize how to close the CAPA loop and the requirements to close CAPAs in a timely and complete manner.

Price: $1200.00

CQI & IRCA-certified QMS Lead Auditor based on ISO 13485:2016 and MDSAP Requirements

This virtual instructor-led CQI/IRCA accredited course provides learners with the skills and knowledge that have taken many ​experienced ​auditors ​decades ​to ​develop. This course is fundamental to achieving CQI/IRCA Lead Auditor status. ​During ​the ​course, ​learners ​will ​plan, perform, ​and ​report ​audits ​based ​on ​case ​studies ​that ​simulate ​internal, ​supplier, ​and ​third-party ​audits ​utilizing ​MDSAP ​audit criteria. ​Learners ​will ​participate ​in ​simulated ​auditing ​exercises ​that ​include ​planning and performing audit activities, ​evaluating ​audit ​evidence, and documenting audit findings.

The course consists of five days of interactive instruction and auditing sessions followed by a comprehensive written examination on day six. Learners will have two hours to complete the exam, which is provided and proctored in a virtual format (additional time will be added for non-native English-speaking learners, and learners with disabilities).

Learners should enter the QMS Lead Auditor course with a basic understanding of ISO 13485:2016. Mandatory prerequisite reading and a prerequisite competency assessment will be provided upon enrollment. These prerequisites must be completed in advance of the course start date.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

This class is helpful for all personnel involved in preparing, conducting, managing, participating in, or otherwise facilitating internal, supplier, or regulatory audits and their outcomes, as well as executive personnel with responsibility for the design and implementation of any aspect of a quality management system.

By the end of this course you should be able to:

· Describe the purpose of:

  • Quality management systems
  • Quality management system standards
  • Management system audits
  • Third-party certification

· Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011:2018

· Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485:2016 and MDSAP participating country-specific requirements.

Price: $2800.00

MDSAP Internal Auditor Training

This virtual instructor-led course was designed and developed by the Medical Device Single Audit Program (MDSAP) Lead Project Manager responsible for the team that designed, implemented, and maintained the MDSAP program.

This training focuses internal auditors on the applicable MDSAP country-specific requirements that are applicable to the auditee organization. This focus, when used in conjunction with an existing ISO 13485 internal audit program, will provide the comprehensive coverage necessary to assure all applicable MDSAP regulatory requirements are audited. In addition, resources and insight into how MDSAP Auditing Organizations establish competence of their auditors will be discussed.

An “MDSAP Lite” audit tool will be provided including country-specific requirements and hyperlinks to the specific regulatory requirements (audit criteria) relative to each country-specific requirement. Through expertly designed individual and group tasks and activities, learners will demonstrate how to identify applicable country-specific requirements, how to plan the time necessary to conduct the audit of applicable country-specific requirements, how to plan an MDSAP Lite audit, as well as how to identity, document, and grade country-specific nonconformities.

This training is essential to anyone engaged in planning or conducting internal audits of an organization participating in MDSAP.

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Describe an MDSAP Audit and identify criteria used during an MDSAP Audit
  • Recognize International Medical Device Regulators Forum (IMDRF) governing procedures relative to MDSAP Auditing Organizations
  • Recognize the competency and training requirements for AO auditors
  • Recognize the structure and utility of the “MDSAP Lite” internal audit approach and “Toolkit”
  • Calculate audit time and plan an MDSAP Lite internal audit
  • Identify nonconformities, write nonconformity (NC) statements, and support the nonconformity statements with audit evidence
  • Identify post-audit MDSAP activities including NC grading
  • Recognize the outcomes and goals of an MDSAP audit

Price: $1200.00