QMS COMPLIANCE/SUPPORT

QMS compliance is a key requirement for medical device manufacturers. Compliance with QSR/ISO 13485 is mandatory prior to placing your product on the market (whether in USA, EU, Canada or Australia). ProMedoss can help you with all aspects of your QMS compliance needs.

Establishing your Quality System and writing all relevant SOPs

Our experienced staff will help you prepare your quality policy manual, create detailed work instructions, and customize templates and forms that increase efficiency, paving the way to ISO 13485 and QSR compliance.

Full/Partial internal Quality System audits

Internal audits are a mandatory requirement of Quality Management System, focusing either on your system as a whole or on particular areas of your process where noncompliance may be an issue; in instances where conflicts of interest may occur, ProMedoss can conduct such audits to aid you fulfill this requirement.

Mock FDA/NB audits

As an unassociated third party we can conduct internal audits, mimicking everything FDA/NB will review during an actual audit. A mock audit is the best way your company can prepare for an actual audit by a regulatory agency.

Supplier audits

We can conduct on-site auditing for your critical suppliers to ensure activities you contracted them for are being executed according to your specifications and applicable regulations

Gap analysis (ISO 13485 vs QSR vs CAN/CSA ISO 13485 etc.)

While QSR is largely based on ISO 13485 in order to comply with both, a gap analysis should be conducted and those gaps need to be addressed. Slight variations exist between various countries and their regulatory authorities’ requirements. Our professionals have extensive experience in helping companies simultaneously comply with various regulating agencies, and we can do the same for you.

Representation during FDA inspection

If you receive advanced notice of an upcoming FDA inspection our experts are available to participate and aid with the inspection process and provide real-time guidance and assistance to the company during this stressful process.

QMS Staff

Our experts are available to provide onsite or online general QMS training or custom training on your company-specific procedures and work instructions detailed in your QMS.

 

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