Successfully passing audits while keeping quality bureaucracy minimal

An effective and sustainable Quality System will be the basis of your business success. The value contribution of your quality assurance department will increase through stable and reliable processes maintaining the fulfillment of all regulatory requirements.

MedSysCon offers support for:

  • ISO 13485 – QM systems for manufacturers of medical devices
  • ISO 9001 – Requirements on a quality management system
  • FDA 21 CFR 820 Quality System Regulation
  • Preparation and support for FDA audits and inspections
  • Supplier and internal audits

ISO 13485 and QM Systems

We assist you and your suppliers of medical devices with the implementation of relevant requirements of ISO 13485.

21 CFR 820 QSR. Requirements of the FDA.

MedSysCon supports manufacturers of medical devices on all issues related to the requirements of the FDA. We assist you in the area of quality assurance, premarket approvals or notifications, registration and distribution for your medical devices in the USA. Benefit from our expertise for communication with the federal agency FDA.

The FDA requires medical device manufacturers to implement a quality system that meets the Quality System Regulation (QSR) for medical devices found in 21 CFR Part 820. The QSR is similar to the ISO 13485 standard for quality management systems, but not the same.

Inspections by the FDA

The FDA is obligated to inspect manufacturers of medical devices in compliance with 21 CFR 820 QSR at regular intervals. Do not take any risk of receiving major findings or a warning letter from the FDA.
With a gap analysis we reveal existing inconsistencies in your quality management and take the appropriate actions to comply with the Quality System Regulations 21 CFR 820th.

MedSysCon: ISO 13485

ISO 13485

Quality Management according to the accepted standard

MedSysCon: Qualitätsmanagement nach den Anforderungen der FDA

21 CFR 820 QSR

Quality Management according to the requirements of the FDA.

MedSysCon: FDA Inspektionen

FDA inspections

The FDA inspects manufacturers of medical devices in at regular intervals.

Your Benefits

  • Market- and need-based QS tailored to your company with appropriately high internal and external acceptance
  • Fulfillment of applicable regulatory requirements while simultaneously avoiding over-interpretation
  • Securing your business success through targeted and cost-conscious quality management processes
Do you have questions on the subject Quality Management?

We will be happy to provide you with comprehensive advice.

Contact us