KARA & Associates can assist with your medical device regulatory needs. We help assure compliance with global regulations including FDA, MDSAP, EU Regulations, training and ISO requirements.
Our team of highly skilled regulatory compliance professionals deliver timely, consistent, cost effective results. We will work with your personnel to find solutions to help your company bring your products or services to market quickly. Some of our key regulatory consulting services are listed here; contact us to discuss your specific needs.
Services we provide are:
- Crisis intervention to FDA audit response (483), warning letters, and product recalls
- Supplier audits/Monitoring
- Regulatory strategy development, pre-market submissions, 513(g), De Novo submissions, and FDA review
- GMP/QSRs compliance to 21 CFR 820, 803, 806, 211,210
- CE Marking, EU Directives and New EU Regulations, Canada (CMDR), Australia (TGA); Japan (JPMDL) new requirements, MO 169; ISO 13485:2016, MDSAP
- Quality manual and procedure preparation
- On-site audits, validation (process, software & sterilization)
- Development of quality assurance systems
- F510(k)s — Premarket notification submissions
- Assist with medical device listings
- Product labeling compliance and IFU (instructions for use) development and pre-submission review
- Conduct inspection audits and mock inspections
- Internal Audits for compliance
- US Agent for Foreign Manufacturers