Optimizing quality systems to advance your businessMedDev | Expert Medical Device Consulting
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
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.
Have you recently received a major nonconformance from a notified body audit, or an FDA 483, Warning Letter or consent decree? We can help formulate your response, identify corrective actions and assist with implementation activities to ensure this does become a repeat observation.
Clearance from US or international government regulators is typically required prior to selling your product in those markets. We can research the regulatory requirements and compile all documents necessary for a regulatory submission.
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.
We want you, as a start-up company, to focus on what you do best, developing and commercializing your new product ideas. Benefit from our experience and past successes helping start-ups set-up the systems needed to design and distribute your product.
We can custom tailor training programs around your quality system or take advantage of our FDA and ISO based training programs. All training is conducted on-site at your facilities to minimize travel costs and disruption to your operations.
Top 15 FDA Inspectional Observations (483s) FY2019
- Design Controls – 820.30 | 384 100% 100%
- Corrective and Preventive Action – 820.100 | 379 99% 99%
- Complaint Files – 820.198 | 347 90% 90%
- Purchasing Controls – 820.50 | 239 62% 62%
- Medical Device Reporting – Part 803 | 213 55% 55%
- Records – 820.18x | 189 49% 49%
- Process Validation – 820.75 | 179 47% 47%
- Production & Process Controls – 820.70 | 175 46% 46%
- Nonconforming Product – 820.90 | 175 46% 46%
- Acceptance Activities – 820.8x) | 174 45% 45%
- Quality Audit – 820.22 | 139 36% 36%
- Management Responsibility – 820.20 | 123 32% 32%
- Document Controls – 820.40 | 113 29% 29%
- Personnel/Training – 820.25 | 95 25% 25%
- Inspection, Measuring & Test Equipment – 820.72 | 78 20% 20%
To request a more detailed breakdown of FDA Inspectional Observations, complete the contact form below:
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