Audits and Inspections

Audit & Inspection Services

 

In order to legally and successfully design, manufacture, sterilize, import, promote and/or distribute medical devices on domestic and global markets, companies must first have the necessary quality management system (QMS) properly established and operating. Applicable regulations and standards require that companies engaged in medical device activities establish appropriate procedures for mandatory internal QMS/quality audits, to check the ongoing compliance of each medical device company facility. If a company fails to conduct an appropriate internal audit according to the company procedure and established audit schedule, they run the risk of operating out of compliance with applicable regulations and/or standards. Unfortunately, any such resulting undesirable non-compliant situation could be discovered during an FDA inspection, MDSAP/ISO audit, M&A due diligence audit, or other such activity. 

 

However, internal company staff are often the least objective auditors when comparing their own company operations to the applicable regulatory requirements. To avoid any costly remediation activities to correct non-compliance situations, medical device companies should consider using the best QMS consultant available to discover any compliance problems as early as possible. Ken Block Consulting frequently conducts internal QMS/quality audits, supplier audits and independent regulatory compliance gap analysis audits (FDA, MDSAP, ISO, etc.) at all types of medical device companies (specification developers/designers, sterilization facilities, manufacturers, contract manufacturers/suppliers). In addition, our unique risk-based audit reporting approach provides our clients with actionable priorities in addressing any discovered problems. Ken Block Consulting offers on-site/in-person audit services as well as remote/virtual audit services, to meet every client situation. 

 

Inappropriately addressed compliance problems can quickly become serious and expensive. In one such past example, Ken Block Consulting was approached by a large multinational medical device manufacturer, six months after they had received a Warning Letter from FDA regarding two of their four company facilities. Despite prior assistance from two of our competitors over six months, their compliance situation had not been resolved - FDA remained unhappy with QMS progress and the manufacturer was subject to an active Department of Justice investigation regarding their company activities. Ken Block Consulting conducted an independent FDA compliance gap analysis of all four company facilities (one design, three manufacturing), where dozens of yet unidentified critical-risk and major-risk QMS deficiencies were discovered. We then replaced our competitors, created and implemented the comprehensive remediation plan on-site at all four facilities, and successfully addressed the systemic QMS problems to resolve this serious compliance situation. 

 

In addition to conducting pre-audit and pre-inspection examinations of client operations, Ken Block Consulting expertly prepares and trains companies of all sizes - from startups to multinational corporations - regarding the practical handling of FDA inspections, MDSAP and ISO audits, M&A due diligence audits and other similar activities. We also efficiently and effectively manage the eventual inspection or audit activities, as well as successfully lead the necessary efforts in successfully resolving any identified compliance problems such as FDA Form 483 Observations, FDA Warning Letters, ISO/CE Notified Body and MDSAP non-conformances (NCs), etc. With offices in the US, Europe and Asia, our global team tackles audit and inspection activities worldwide. 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

FDA 21 CFR Part 820 Compliance Gap Analysis Audit  +

  • Audit of quality documents and records
  • Interviews with key quality personnel
  • On-site tour for visual assessment
  • Corrective action suggestions using your CAPA process

Mock FDA Inspection   +

  • Set up and rehease as if you are having an FDA inspection

FDA Inspection Support   +

  • On-site support while FDA inspection is conducted
  • Post-FDA inspection support if voluntary actions are required

ISO 13485:2016 Compliance Gap Analysis Audit   +

  • Audit of quality documents and records

MDD/MDR Compliance Gap Analysis Audit   +

  • Audit of quality documents and records

MDSAP Compliance Gap Analysis Audit (Medical Device Single Audit Program)   +

  • Audit of quality documents and records

Internal Quality Audit   +

  • Audit of quality documents and records

Supplier Evaluation Audit   +

  • Audit of quality documents and records of your supplier's quality system
  • Focuses on specific supply of your interest

e-Audit   +

  • Virtual Communication and remote auditing of quality documents and records