Passarini Blog
Events: goods destined for distribution and more
Resolution RDC n. 13, of January 27th, 2004 - Goods intended for exposure, demonstration or distribution at fairs or events At the last Hospitalar fair that occurred in May 2019 in São Paulo/SP, Anvisa seized several irregular products and closed some stands. One of the [...]
The FDA: cleaning and steam sterilization the IFU
The FDA and its peculiarities in the cleaning and steam sterilization processes recommended in the IFU Medical products that must be cleaned and steam sterilized (autoclave) prior to use or in the case of thermolabile products, cleaned and disinfected prior use, are those marketed as non-sterile [...]
Annual adjustment of FDA medical devices fee rates
September 30 of each year ends FDA Fiscal Year or FY. As a result of this change, there is an adjustment in the FDA fee rates. For the FY 2020, the standard and small business values increased by 6% when compared to the fee rates [...]
ISO 13485: 2016 and its relationship with Computer Systems Validation
ISO 13485: 2016 and its relationship with Computer Systems Validation The newest edition of ISO 13485 was a new approach on the validation of productive processes using computer systems. They are covered by this new approach from high level language software like as ERPs, production [...]
Consulting in Clinical Research
Consulting in Clinical Research In order to offer a complete solution to our customers, Passarni Regulatory Affairs has established a partnership in the clinical research market with GRINN. GRINN is a contract research organization (CRO) specialized in innovative study designs for Clinical Trials, Literature Reviews and Real [...]
What is GMP?
What is GMP? GMP refers to the Good Manufacturing Practices Regulations defined by the Health Regulation and Health Surveillance Agencies of several countries. These regulations, which have the force of law, require manufacturers, processors and distributors of medicines, cosmetics, medical devices and food products to [...]
