Clik here to view.
cGMP – Design Inputs (URS-FRS-MRS-ERS) – ISO 13485:2016 (7) Clause 7
We expect that the Design & Development Plan be a written and reviewed document. Similarly, the Design Inputs also needs to be a controlled document. In practice, the design input document is...
View ArticleClik here to view.
cGMP – Design and Development Outputs (SwRS-MecRS-HwRS-FwRS) – ISO 13485:2016...
In the same manner that we have design and development input. We also have design and development output. The result of satisfying the criteria for design input is the design output. The output will...
View ArticleClik here to view.
cGMP – Medical Equipment Calibration – How it affect our success – ISO...
Calibration is considered as an essential procedure for any equipment and device, in order to maintain and improve its accuracy and precision. Calibration is the process, in which equipment under test...
View ArticleClik here to view.
OrcaMotive ASPICE Event Madrid Spain 2019
rami.azulay@orcanos.com Tel: +972-3-537-2561 OrcaMotive Event – Madrid Spain 2019 ¡Usted está invitado a nuestro...
View ArticleClik here to view.
cGMP – Design & Development Review Principles
It is quite essential to have a formal design review process. When designs are made or put in place, it is of utmost importance that they are reviewed. A formal review process will help you critically...
View ArticleClik here to view.
CAPA: Corrective and Preventive Actions Introduction Principles – Chapter I
Corrective and Preventive Action (CAPA) is a way to improve the company’s processes. They are a series of actions that eliminate unforeseen events and causes of non-conformities. Likewise, CAPA, as a...
View ArticleClik here to view.
cGMP – Design and Development Master Validation Plan (10)
People in the medical device industry are often wary of the term validation even though they shouldn’t. Validation is using objective evidence and experiment to ensure that a set of requirements are...
View ArticleClik here to view.
CAPA Chapter I: Corrective and Preventive Actions Introduction Principles
Corrective and Preventive Action (CAPA) is a way to improve the company’s processes. They are a series of actions that eliminate unforeseen events and causes of non-conformities. Likewise, CAPA, as a...
View ArticleClik here to view.
CAPA Chapter II: Understanding Non- Compliance in the CAPA System
One of the most recurring issues that the FDA finds during its inspection is the non-compliance to the Corrective Action Preventive Action (CAPA) system. Surprisingly, the non-compliance problem isn’t...
View ArticleClik here to view.
CAPA Chapter II – Driving Source
Often times, we suspect products and process as the main sources for CAPA. However, there are several other areas that we can consider as CAPA sources. They include; Customer Complaints: It represents...
View ArticleClik here to view.
CAPA Chapter III – Root Cause Analysis of the CAPA System
Introduction Root Cause Analysis (RCA) is the heart and soul of the CAPA system. Without defining the root causes or cause of a problem, it would be nearly impossible to prevent from recurring....
View ArticleClik here to view.
CAPA Chapter IV: Actions To Take To Address CAPA Problems
If you discover a non-conformity in your CAPA system is systemic. It means that the non-conformity is realized and it will keep recurring. Then it is time to take action to both correct it and prevent...
View ArticleClik here to view.
CAPA Chapter V: Reviewing The CAPA System and Actions
Overview The FDA and the ISO13485 both demand that the management reviews the status of all PAs and CAs. People tend to ignore the importance of review, and that can be costly for the management. It is...
View ArticleClik here to view.
ORCANOS in MEDICA during 18 – 21 November 2019 in Düsseldorf
ORCANOS In Medica During 18 – 21 November 2019 In Düsseldorf MEDICA is the world’s most significant event for the medical sector. For more than 40 years it has been firmly established on every...
View ArticleClik here to view.
cGMP – DESIGN AND DEVELOPMENT TRANSFER (DMR) (11)
The Device Master Record (DMR) is the ultimate document for ensuring efficient design transfer. It is not a mandatory requirement according to ISO 13485. The DMR is mostly theoretical as it is a...
View ArticleClik here to view.
Passing MDSAP with no paperwork
Orcanos has passed the MDSAP audit successfully with one of its leading medical device customer, led by Irit Bouwman. Irith testified that this was a very successful audit, done purely online. “I was...
View ArticleClik here to view.
RISK MANAGEMENT (01) – INTRODUCTION TO QUALITY RISK MANAGEMENT (QRM)
Are you new to the ISO 14971:2012 & FMEA system or seeking to improve your processes? As a QA representative or Functional Safety Manager, you will find in the following series of posts all the...
View ArticleRISK MANAGEMENT (02) – THE BENEFITS OF FAILURE MODE AND EFFECT ANALYSIS (FMEA)
Interested to know what are the 9 major benefits and what are the 5 top areas you should consider using it? Here in this post you will hear all about the QRM system and the fundamental of the FMEA...
View ArticleClik here to view.
Risk Management (03) – The Regulatory Requirements For Risk Management
Pharmaceutical/Medical Device/Automotive Regulatory Requirements According to regulatory bodies, medical devices, pharmaceutical or automotive manufacturers should be implementing Quality Risk...
View ArticleClik here to view.
RISK MANAGEMENT (04) – WIDELY USED METHODS
Do not know what methods can be used for Risk Management? Below is the list of methods widely used for risk management provided by the ISO 14971, ICH Q9, ASPICE Management Process.5, ISO 26262...
View Article