Poka Yoke and Six Sigma
Poka Yoke or Mistake Proofing is a technique for eliminating defects by making it impossible to create them in the
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Computer System Validation
INTRODUCTION No matter what core services your company provides, if computer systems and software products are involved, efficiency will always
Risk Management in Medical Device
Risk Management in Medical Device The EN ISO 14971:2019 standard specifies a process through which we medical device manufacturer can
What are Clinical Trials?
Clinical trials are any type of human research that is designed to: Detect or validate clinical, pharmacological and /
Deviation Management Process
RS NESS is a highly experienced service provider in the Medical Device and Pharmaceutical industries. We can assist you with CAPA
Purchased Part Approval Process (PPAP)- the next step in supplier quality
RS NESS is a highly experienced service provider in the Medical industry. We can assist you with a PPAP process implementation
IVD Classification Under IVDR
RS NESS is a highly experienced service provider in the Medical industry. RS-Ness can assist you with an IVDR gap assessment
Butterfly effect due to a small part exchange in a Medical device company
RS NESS is a service provider and consulting company in the Life science industry for those who are unfamiliar with
Cleanroom Design
RS-NESS works with various companies to construct production facilities and provide a comprehensive solution for these complex projects. We accompany
Clean Room Construction Project
RS-NESS works with various companies to construct production facilities and provide a comprehensive solution for these complex projects. We accompany
Preparing your QMS for the EU MDR
RS Ness supports Life Science companies in QA, Regulatory Affairs, Clinical Affairs, Engineering, Validation and Project Management. Contact us to support
How to establish DHR
RS NESS supports the Life Science in such field as: Quality Assurance (QA), Regulatory Affairs (RA), Clinical Affairs (CA), Engineering,
Medical Device Roadmap from Idea to Market
Commercializing medical technology is challenging, often requiring 10 – 20 years just to bring new ideas to market. There is
Your Packaging Validation Guideline
RS NESS is a highly experienced service provider in the Medical industry. RS Ness can assist you with Packaging and
The Nanosono journey- from idea to ISO13485 Certification
RS NESS supports Medical device companies in rapid scale-up and meeting GMP compliance requirements; proving the experience you need when
Validation of Medical Device manufacturing line for getting the European CE mark certification.
RS NESS is a highly experienced service provider in the Medical industry. RS-Ness can assist you with a gap assessment to
Supplier evaluation and approval in 5 steps.
RS-NESS supports Life Science companies in rapid scale-up and meeting GMP compliance requirements; proving the experience you need when you
Preparing your Quality Management System for the MDR: QA Best Practices
RS-Ness supports Life Science companies in QA, Regulatory Affairs, Clinical affairs, Validation and Project Management. We will assist you with
If you have 2 months to establish an EU-GMP compliant production line for Medical Cannabis, what should you do?
RS NESS supports Life Science companies in rapid scale-up and meeting GMP compliance requirements; proving the experience you need, when
Process Validation: Pharma vs. Medical Device
RS-NESS provides an umbrella of services to the Life Science industry in the areas of validation, quality assurance, regulatory affairs, clinical affairs,
MDSAP In 60 Sec
For those who are not familiar with the Medical Device Single Audit Program (MDSAP), it is a harmonized approach for