In Vitro Devices (IVDs) are typically treated as a subset of medical devices. They provide information for diagnostic, monitoring and compatibility purposes by means of in vitro examination of specimens derived from the human body e.g. blood, tissue, urine and hair.
In most cases IVDs are regulated within the (old) Global Harmonisation Task Force (GHTF) guidance documents, i.e. the IMDRF. This is not the case for all as some countries govern IVDs by separate regulations.
We can help with determining which regulations you need to comply with and how to achieve compliance without sacrificing business success.
All the regulators are increasingly looking at how device companies manage the risk to product quality associated with their suppliers. The “Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 5: Audits of Manufacturer Control of Suppliers”, originally released by the GHTF (now IMDRF) should be used to audit your suppliers.
PharmOut is privileged to have several consultants who have had years of experience as TGA and PIC/S auditors. They know the relevant international regulatory codes for Medical Devices (with IVDs being a subcategory) e.g. QSR 820, ISO 13485, ISO 14971 and the GHTF QMS (IMDRF) for medical devices.
Receiving a notice of deficiencies after an audit by a regulator is never pleasant. For some companies it will mean major remediation efforts are required, for others it may mean having to address a few small issues. PharmOut can help you prepare your audit response.
If you already have a facility design, we can provide an independent GMP review to make sure that all the important details are covered and nothing has been missed before the property lease is signed and the cement is poured.
If you are resource-poor and need experienced, professional GMP contractors to help get a job done or a project completed, then we can supply contractors with a range of GMP skills and knowledge.
PharmOut can demonstrate how to apply processes such as Lean Manufacturing and Six Sigma within the regulatory constraints of the Pharma industry.