Optimizing quality systems to advance your businessMedDev | Expert Medical Device Consulting LEARN HOW
Achieving quality system compliance is a team effort and without the commitment from everyone on the team, it will most certainly fail.MedDev | Expert Medical Device Consulting ABOUT US
Our mission is to lead companies to increased compliance and profitability through optimized processes.
Shrinking margins from competitive pricing and reduced reimbursements may result in sacrifices in product quality and regulatory compliance. This does not need to be the case. Explore our solutions to help you optimize your processes while increasing regulatory compliance.
Besides being a regulatory requirement, validation studies are the best way to identify process variability and methods to control it. We can assist with equipment, process, test method, software, packaging, cleaning and sterilization studies to support submissions, reduce inspection or re-do existing validations.
Audits are one of the best methods to assess the level of compliance for in-house and supplier quality systems. We can perform audits to satisfy annual quality system audit requirements, preparation for third party inspections, and gap assessments of specific quality system areas.
Top 10 FDA Inspectional Observations (483s) FY2015
- Records-Subpart M (820.180, 820.181, 820.184, 820.186, 820.198) | 697 100%
- Production and Process Controls-Subpart G (820.70, 820.72, 820.75) | 543 78%
- Design Controls-Subpart C (820.30) | 538 77%
- Corrective and Preventive Action-Subpart J (820.100) | 477 68%
- Quality System Requirements-Subpart B (820.20, 820.22, 820.25) | 425 61%
- Medical Device Reporting (Part 803) | 294 42%
- Purchasing Controls-Subpart E (820.50) | 248 36%
- Acceptance Activities-Subpart H (820.80, 820.86) | 216 31%
- Nonconforming Product-Subpart I (820.90) | 209 30%
- Document Controls-Subpart D (820.40) | 108 15%
To request a more detailed breakdown of FDA Inspectional Observations, complete the contact form below:
Contact | Inquire
“Simplicity is the ultimate sophistication” ―Leonardo da Vinci