Accurate Consultants will immediately supplement your organization to provide various quality system solutions, which will comply with ISO 13485:2016 Quality Management System Regulation (QMSR) as well as International Regulatory Authorities regulations and standards such as EU Medical Device Reporting (MDR). Accurate Consultants can engineer and supply you with the appropriate QMSR or EU/MDR compliant documentation and training. Our Quality System solutions can be customized and implemented into your organization in a seamless way for simplicity and for long term sustainability.

Medical Devices/IVDs: Accurate Consultants can prepare and implement an entire QMS system and act as your firms interim quality manager or just act as an advisor on a specific subsystems to meet the FDA QSMR and ISO 13485:2016 compliance. We have developed and understand the different requirements for Class 1, 2 and 3 medical devices and can tailor a QMS depending on the risk and classification of the product.

Our quality system program for Medical Devices and IVD manufacturers focus on the proper implementation and sustainability of the following subsystems which aligns directly to ISO 13485:2016 and QMSR:

1) Management Oversight
2) Change Controls
3) Design and Development
4) Measurement, Analysis and Improvement – Complaints, CAPA, Nonconforming Product, Internal Audits
5) Outsourcing and Purchasing
6) Production and Service Provisions and Controls
7) Risk Management

Additional Critical Components:

• Medical Device Reporting (21 CFR Part 803)
• Medical Device Traceability/UDI
• Corrections and Removals

We also provide assistance to any Medical Device or IVD firms that need assistance developing a Technical File and seeking CE marking for entry into the EU marketplace. We have deep expertise in Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) and can help your firm develop the Quality system required for compliance.

Cell and Tissue Therapy: Accurate FDA Consultants can assess, prepare and implement a system compliant Good Tissue Practices (GTP) Quality System (21 CFR Part 1271) or provide guidance and expert feedback on your firms current system for improvement and sustainability. We can conduct on-site or off-site/remote GTP audits to verify and confirm 21 CFR 1271 compliance. Accurate Consultants is also experts in training and compliance consulting in the CGTP regulations as well, with experience assisting multiple firms in the tissues industry.

Contact Us Today!

Contact us today for a non-obligatory consultation and quote. Let’s discuss your needs and scope of any quality system implementation or improvement project.