Expert Training in Medical Device & IVD Regulations
Medivdpharma (MIP) provides specialized training programs to help medical device and IVD manufacturers navigate complex regulatory landscapes, ensure compliance, and accelerate market access. Our expert-led sessions equip your team with the knowledge and skills needed to thrive under evolving frameworks like the EU MDR, UK MDR, and IVDR.
Why Invest in Regulatory Training?
- Avoid Costly Delays: Missteps due to regulatory ignorance can lead to rejected submissions, audits failures, and product recalls.
- Build Audit-Ready Teams: Documented training is critical for passing regulatory audits and inspections.
- Empower Your Workforce: Foster a culture of compliance and quality from R&D to post-market surveillance.
- Streamline Operations: Consistent understanding across departments reduces errors and enhances collaboration.
Our Training Services
We offer customizable, hands-on training modules tailored to your organization’s needs:
- Risk Management (ISO 14971:2019)
- ISO 13485 Compliance
- Medical Device Technical Files
1. Risk Management (ISO 14971:2019)
- Full Lifecycle Risk Management: Learn to identify, evaluate, and mitigate risks throughout the product lifecycle.
- Hazard Analysis & FMEA: Master techniques for Design FMEA (DFMEA) and Process FMEA (PFMEA) to support regulatory submissions.
- Practical Workshops: Apply risk management principles to real-world scenarios.
2. ISO 13485 Compliance
- QMS Fundamentals: Understand the requirements of ISO 13485 for medical device quality systems.
- Gap Analysis & Remediation: Identify weaknesses in your current QMS and align with global standards.
- Audit Preparation: Gain confidence to face notified body and regulatory audits.
3. Medical Device Technical Files
- MDR/IVDR Documentation: Learn to structure and maintain compliant technical documentation.
- Audit-Ready Files: Develop strategies to ensure your technical files withstand regulatory scrutiny.
- Best Practices: Keep documentation updated through iterative design and post-market changes.
Why Choose MIP for Training?
Expert Trainers
Learn from professionals with decades of experience in regulatory affairs, quality systems, and notified body audits.
Time-Saving Solutions
Offload training development and delivery to focus on core business activities.
Bespoke Content
Training tailored to your products, processes, and regulatory goals.
Documented Proof
Receive training certificates and records to demonstrate compliance during audits.
Who Should Attend?
- R&D and Design Engineers
- Quality Assurance and Regulatory Affairs Teams
- Clinical and Manufacturing Staff
- Senior Management and Project Leaders
