Popular ISO 9001 Quality management > ISO 13485 Quality management for medical devices > ISO 22301 Business continuity > ISO/IEC 27001 Information security > View all standards >
Access and buy standards How to access and buy > Decide which option works best for your business Buy standards > Standards subscriptions > BSOL > Full standards collections Compliance Navigatior > Medical device standards
Auditing, certification and training Assessment and ISO certification > ISO certification and others eg: IATF, FSSC Auditing and verification > Supplier audits, custom audits and internal audits Product testing and certification > BSI Kitemark, CE marking and verification, Market access solutions Validate BSI-issued certificates > Check company, site and product certificates
Training courses > Individual, group and company-wide training Medical devices services > CE marking for medical devices, MDR and IVDR, quality management for medical devices Compliance software and solutions > Software tools and solutions for governance, cyber security, risk and supply chain management
Industry reports, research and news Digital construction > BIM, smart cities and connected assets Future of mobility > Global market access > Health, safety and wellbeing > Information security > Cybersecurity, privacy (GDPR) and compliance
Innovation > Internet of things (IoT) > Organizational resilience > Sustainability > - Circular economy > View all topics >
About BSI > BSI impartiality > Our accreditation > Our clients and partners > Our financial information >
Our legal information > Our purpose, mission and vision > Our Royal Charter > UK National Standards body > The global role of BSI as the national standards body >
Careers > Events and webinars > Media centre/press room > Sustainability > Modern slavery statement Contact us >
CE Marking > European MDD > ISO 13485 Quality Management > MDSAP > Compliance Navigator > EN 60601 Medical Electrical > ISO 14971 Risk Management > Global medical solutions > View all services >
Popular topics EU Referendum Result > ISO 13485 Revision > IVDR Revision > MDR Revision > Unannounced Audits > Transfer to BSI > Role of a Notified Body > Product Lifecycle >
AIMD > Active Devices > Ancillary medicinal substances > In Vitro Diagnostics > Devices utilizing animal tissue > Electronic Cigarettes > Microbiology and Sterile Devices > View all technologies >
Mobile Devices > Nanomaterials > Ophthalmic Devices > Orthopaedic and Dental Devices > Software as a Medical Device > Vascular Devices > Woundcare > DuPont™ Tyvek® Transition Project >
Webinars > White papers > Training courses > Brochures > Newsletters > Events > Industry guidance > Case studies >
Manufacturing Process Validation for Medical Devices: Introduction to Concepts and Methods Training Course This one-day intensive course enables greater understanding of the key requirements for manufacturing process validation for medical devices, in line with the European Medical Device Regulations (MDR) and ISO 13485:2016 requirements in Europe. The aim of the course is to enable manufacturers to know what process validation evidence is necessary to demonstrate the manufacturing process is validated. BSI’s ‘Manufacturing Process Validation for Medical Devices: Introduction to Concepts and Methods’ one-day training course has been designed to give manufacturers an awareness of EU regulatory and quality requirements regarding manufacturing process validation and the nature of ‘special processes’. Practical activities throughout the day provide the opportunity to apply your knowledge. Learn the generally accepted principles of manufacturing process validation, understand installation, operational and process qualification so you can apply them to your organization. Who should attend? This course is ideal for you if you’re in a quality assurance/regulatory/engineering/ manufacturing role involved in medical device design, development and manufacturing. Pre-requisites You should have experience or basic knowledge of manufacturing engineering or quality management systems for the medical device industry. We recommend you have a basic awareness of medical device development and quality assurance. "The course was delivered at the right pace." What will I learn? On completion of this training, you’ll be able to: Appreciate concepts and rationale of manufacturing process validation Recognize the importance of manufacturing process validation Gain awareness of relevant ISO 13485:2016 expectations and IMDRF guidance (previously GHTF) Recognize situations where a manufacturing process requires validation Have the tools to create a Master Validation Plan and validation protocols Define objectives of equipment and process validations Recognize relevant and pertinent factors of manufacturing process validation studies Plan for worst case conditions and challenges Identify how process capability studies can be used to validate manufacturing processes Complete installation, operational and performance qualification Maintain a state of validation Recognize when revalidation may be required How will I benefit? This course will help you to: Understand manufacturing process validation Improve your understanding of the regulatory and quality standards requirements relating to manufacturing process validation Be able to apply your knowledge to your organization, to enable it to produce compliant devices Ensure auditable technical documentation meets applicable EU regulatory requirements What's included? On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.