Own brand label manufacturing: what’s next?
The strict regulatory requirements of MDR (EU) 2017/745 are about to hit hard a particular category of economic operators: the medical [...]
30 04 2019
30 04 2019
12 03 2019
12 03 2019
Infographic – the Post Market Surveillance process
Starting May 26th, 2021 (the MDR (EU) 2017/745 application date), medical device manufacturers will have to apply the MDR requirements for [...]
14 02 2019
14 02 2019
Revision of the REACH regulation to include nanomaterials: Medical Devices and IVDs impacted
On December 3, 2018, the European Commission issued Regulation (EU) 2018/1881, a specific revision of Regulation (EC) no. 1907/2006 regarding the [...]
06 12 2018
06 12 2018
Person Responsible for regulatory compliance: the Regulatory Affairs expert training
Inspired by the "Qualified Person " role present in the pharmaceutical field, the concept of Person Responsible for regulatory compliance is one [...]
20 11 2018
20 11 2018
Clinical Evaluation Infographic
This Infographic provides an overview of the clinical evaluation process as required by the MDR (EU) 2017/745 and the MEDDEV 2.7 [...]
23 10 2018
23 10 2018
Clinical evaluation: is your Clinical Evaluation Report (CER) compliant with MEDDEV 2.7/1 rev. 4?
With the stricter European Regulations (MDR 2017/745) coming into full effect in 2020, the subject of clinical evaluation has become a [...]
06 09 2018
06 09 2018
MDR and IVDR essential requirements for instructions for use and labelling
It is now time to devote oneself, if not to the study, at least to the reading of the general essential [...]
08 08 2018
08 08 2018
Complaints and reporting management
Let’s suppose that, as a manufacturer of Medical Devices, your company has received a complaint from a customer. This is a [...]
18 07 2018
18 07 2018
The equipment qualification within software process validation
Qualification or validation? The process validation represents both the substantial and formal demonstration of the ability of the process to provide [...]
12 07 2018
12 07 2018
SPAIN: CCPS Portal activation
On June 26, 2018 the Spanish Regulatory Authority AEMPS issued a specific Information Note stating that as of July 4, 2018 [...]
