KARA & Associates can help train and support your staff. Having well-trained and knowledgeable personnel will create a more seamless blend of your company’s regulatory, marketing, and technical departments. Our customized training solutions deliver fast, effective results.

We offer a wide array of quality and regulatory seminars, as well as on-site training that we can provide your staff; in addition, we would be happy to discuss any of your specific training needs.

Onsite training sessions offered in the following topics:

• EU Regulations current and proposed under MDD, AIMDD, IVD
• MDSAP (Medical Device Single Audit Program) how to audit, and review of requirements
• Internal Auditor training based on 21 CFR 820, ISO 13485/MDSAP and other regulations.
• Risk Management Program
• Validations/Protocol writing/review/execution
• Sterilization Validation protocol and report writing/review
• Labeling
• US FDA compliance requirements
• Basic introduction to QSRs and ISO elements
• Labeling Requirements
• Records compliance
• Technical File Requirements
• Vigilance
• ISO 13485:2016 and 21 CFR Section 820 review and comparison
• Japan -JPMDL and new MO. 169 requirements
• Canada CMDR SOR/98-282
• Brazil RDC 16/2013
• 21 CFR 820
• TGA Requirements
• other regulatory and quality related compliance training.