Quality Audits and Gap Assessments
Medical device manufacturing companies are under pressure to release new products, but they also need to make sure their products are safe and compliant with regulations.
Helping medical device manufacturing companies stay compliant and up to date on the latest changes.
MB&A offers quality system audits, gap assessments, and due diligence audits to help medical device manufacturing companies stay compliant and up to date on the latest changes. We have over 25 years of experience in the medical device manufacturing industry and our team of experts and certified lead quality auditors can help your company succeed.
Services We Offer
Audits
MB&A has a team of lead quality auditors ready to provide robust inspections of your quality systems. Without regular monitoring, product quality can begin to decline resulting in a possible loss of third-party certification or FDA enforcement actions. MB&A’s experts can assess your compliance and prepare you for any inspection.
Corporate and Internal Audits
It is hard for organizations to be truly objective. Let us show you how to increase the value of your internal audits while decreasing the cost of your audit program.
Supplier Audits
Ask us how you can reduce the cost of your supplier audit program by outsourcing.
Mock FDA Inspections
Includes mock Pre-Approval Inspections (PAI’s) for PMA submissions.
Current Good Manufacturing (cGMP) Compliance Audits
Risk Assessments
Quality Systems – 21 CFR Part 820 & ISO 13485:2016
MDSAP Readiness Audits
IEC 62304
ISO 27001
Gap Assessments
If you are interested in starting a new business or adding to your manufacturing portfolio, MB&A can assist you with a GAP Assessment to identify exactly what is needed to go from noncompliance to full compliance.
ISO 13485:2016 Medical Device
Medical Device Single Audit Program (MDSAP)
EN ISO 14971:2012
IEC 62394
ISO 27001
Problem Resolution
Medical device manufacturing companies sometimes find themselves in a position to respond formally to issues identified by FDA and other third parties. Our team of experts has over 25 years of experience managing crises and resolving these issues. We can handle anything from resolving an FDA Warning Letter to creating a compliant CAPA process. You can rely on our expert experience and track record of successful problem resolution.
Services include…
Assistance in creating complaint processes, including FDA medical device reporting (MDR) to comply with 21 CFR Part 803, and improving complaint investigations
Management of recalls in accordance with 21 CFR Part 806
Assistance in creating processes for vigilance reporting (VR) for CE-marked devices
Improve conforming product processes
Improving document control systems, including compliance with 21 CFR Part 11 for electronic signatures and electronic record-keeping
Improving CAPA processes, which are among the most common sources of FDA 483s
Resolving FDA 483s and warning letters with quality system updates
Resolving notified body ISO 13485 audit observations
Supplier Management
Supplier management is a critical area for most medical device manufacturing companies. With the latest MDR changes and COVID supply chain crisis, Supplier Management is more important than ever. Our team of Quality and Strategic Sourcing experts can handle:
Supplier Selection
Supplier Evaluation
Supplier Negotiation
Supplier Monitoring
Supplier Quality Agreements
Supplier Audits
Due Diligence
In the fast-paced world of life sciences companies, businesses are acquired every week. The team at MB&A has represented some of the biggest names in the business during due diligence audits. We are prepared to represent either the buyer or the seller. We have a library of due diligence checklists that have proven effective over dozens of deals.
