ISO 13485 Quality Coaching
Coaching and case-based co-training for quality auditees with, and quality auditors of, medical device quality management systems.
Start-up quality professionals are often ‘homegrown’ or attracted from mature companies. This means they have just started their journey, or haven’t adapted yet to the new challenges and opportunities that a smaller company brings.
To aid these professionals, Medace offers the opportunity of a coaching/training retainer. In this arrangement your quality professional can contact Medace regularly, in bite-sized amounts suited to their case at hand.
Target group
- Start-up personnel newly stepping into the quality or regulatory role, or otherwise made responsible for the QMS.
- Quality personnel in medtech who wish to develop their knowledge, skills, and abilities.
- Experienced quality personnel who wish to hone their skills or cross-train to different medical device types.
- Professionals desiring to shift into quality roles from other medtech departments.
ISO 13485 Quality Coaching
During the course you will be able to:
- discuss your challenges and plot solutions
- round out or deepen your needed knowledge
- develop technical skills for conducting audits or writing reports
- refine nonconformities, as well as the follow-up to nonconformities
- review and refine your tools for auditing
- stay up-to-date on what is relevant for auditors
- learn to communicate a message appropriate to each audience; from auditee, to next year’s auditor, as well as executives and cross-organizational.
- strategically guide professional development, to cover audit programme management or beyond
The coaching will primarily be scheduled to occur with Medace’s Quality Manager MD or GMP, unless specific expertise is more suitable to the case brought forward.
Due to Medace’s unique service offering, support for personnel performing self-inspection for GMP ATMP companies can also be discussed.
let us know you’re interested
Experts
Jean Blom – Quality Manager Medical Devices at Medace
Jean Blom is accountable for the daily quality assurance activities as Medace’s Quality Management Representative, and provides the strategy regarding medical device client planning, coordination, and execution.
He is the principal expert regarding quality requirements as defined by standards (ISO/IEC/EN), and their interactions with regulations such as the EU’s MDR (2017/745).
Before Medace, he worked hands-on in quality and regulatory for a start-up’s class IIA Active Diagnostic Medical Device, and as the quality systems-focused officer at a major multinational medical device developer and manufacturer in the ophthalmic surgery segment with a large variety of devices and operations; this provides him with a breadth and depth of experience that is both useful and familiar to Medace’s diverse client base.
Jessica Gerards – Quality Manager GMP at Medace
Jessica Gerards is specialized in the area of Regenerative Medicine development, with the focus on ATMP. Jessica ensures compliance with international quality standards and guidelines to accelerate the development of her clients’ products towards patients.
Other training opportunities
Do you have a question about this training?
Contact Kurt Gielen
kurt.gielen@medacespace.com
About Medace
Medace supports academic groups and companies with innovative medical concepts in need of technical, quality and clinical expertise. Bringing along a broad network, we help you to successfully develop your product into the clinical phase. With our proven pick-and-choose concept we provide you clinical product development compliant with the latest ISO and GMP standards.
Our specialists work together with you and your team in a fully equipped and state of the art biomedical co-working space – whenever it suits you. More about Medace.
