White Papers

COPQ in the Pharmaceutical Industry

NSF Health Sciences

COPQ is increasingly valuable for the pharmaceutical and medical device industries, where maximising product quality is paramount and defect reduction has an additional knock-on effect.

COPQ in the Pharmaceutical Industry

Five Key Processes for GMP Deviation Investigation

NSF Health Sciences

When things go wrong, there are five non-negotiable processes that should be defined on your deviation investigation standards of practice (SOP): immediate engagement, gemba, triaging using a documented risk assessment, using the Klein process to det...

Five Key Processes for GMP Deviation Investigation

Are You Ready for UDI?

Dassault Systemes

In an effort to improve the quality of information in medical device adverse event reporting, reduce recalls and improve patient safety, in 2007 the United States Congress passed legislation directing the FDA to develop regulations establishing the u...

Are You Ready for UDI?

New EU Medical Device Regulation Adopted

NSF Health Sciences

This year has brought significant changes to the regulatory landscape across Europe, following the publication of the new European medical device regulation (MDR) and in-vitro diagnostics regulation (IVDR).

New EU Medical Device Regulation Adopted

Are You Facing a Complexity Crisis?

NSF Health Sciences

In this whitepaper, Martin Lush discusses the issue of over-complexity in the pharmaceutical industry.

Are You Facing a Complexity Crisis?

Deficiencies in QMS

NSF Health Sciences

The MHRA has been one of the few regulatory authorities to publish the statistics and classifications for the deficiencies it finds during inspections.

Deficiencies in QMS

MiniCollect® Capillary Blood Collection Tubes

Greiner Bio-One Preanalytics

Greiner Bio-One has developed a newly-designed capillary blood collection tube featuring an integrated collection scoop and a co-molded cap for collection and sampling.

MiniCollect® Capillary Blood Collection Tubes

EU Medical Device Regulations: Are You Ready for the Impact?

NSF Health Sciences

Establishing in-vitro diagnostic products and medical devices in Europe may mean making changes to your business beyond comprehension of new regulatory requirements.

EU Medical Device Regulations: Are You Ready for the Impact?

Beyond the ID: the Value of UDI Championing the Patient

Dassault Systemes

The implementation of unique device identification (UDI) will have a profound effect on med-tech manufacturers, healthcare providers, regulators and ultimately the patient.

Beyond the ID: the Value of UDI Championing the Patient

Total Product Lifecycle Solutions for the Medical and In Vitro Diagnostics Industry

NSF Health Sciences

NSF Health Sciences Medical Devices team are recognised as training-experts for regulatory and quality, as well as for consultancy and auditing.

Total Product Lifecycle Solutions for the Medical and In Vitro Diagnostics Industry

FDA Issues Draft Guidances With New Regulatory Pathway Options for PMA Products

NSF Health Sciences

In April 2014, the FDA released draft guidance documents for premarket approval, Balancing Premarket and Post-market Data Collection for Devices Subject to Premarket Approval (PMA) and Expedited Access for Premarket Approval Medical Devices Intended ...

FDA Issues Draft Guidances With New Regulatory Pathway Options for PMA Products

Preparing for Unannounced Inspections from Notified Bodies

NSF Health Sciences

Vice-president of Europe-health sciences medical devices at NSF International has offered advice on how to prepare for unannounced audits by notified bodies after Europe introduces further measures.

Preparing for Unannounced Inspections from Notified Bodies

Force Sensors For Design

Tekscan

In recent years, factors such as consumer demand and a tough economy have pushed OEMs to produce sleeker, smaller, and less costly products than in the past.

Force Sensors For Design

Beyond Trade-offs: How Medical Device Manufacturers can Balance Innovation, Quality and Compliance While Improving Profit

Dassault Systemes

The medical device industry has always been dependent upon product innovation to drive growth. With today's aging global population and expectations for living to an older age, the medical device industry is poised for a sustained period of extreme g...

Beyond Trade-offs: How Medical Device Manufacturers can Balance Innovation, Quality and Compliance While Improving Profit

Changing the Quality Culture

NSF Health Sciences

People are generally happy sticking to what they know, to their tried and tested habits as it is easy and painless.

Changing the Quality Culture

Improving Medical Devices With Force Sensing Technology

Tekscan

Design engineers integrate force sensors into medical devices to create smart tools that produce quantifiable data.

Improving Medical Devices With Force Sensing Technology

Laser Measurement Solutions for Medical Applications

Ophir Photonics

As with any precision industrial process where results must be tightly controlled and predictable, laser-based medical processes must also be controlled and predictable.

Laser Measurement Solutions for Medical Applications

IntelliSorb® Sorbent Formulations

Multisorb Technologies

IntelliSorb Sorbent Formulations offer steady state or multi-functional control of moisture, oxygen, and volatilised organic compounds.

IntelliSorb® Sorbent Formulations

Calculations through Operations

Multisorb Technologies

Multisorb uses its SimulSorbTM and SimulOxTM proprietary pseudo-empirical modelling programs to design an optimised sorbent solution for moisture, oxygen, and volatiles management based on parameters specific to a product.

Calculations through Operations

Connecting the Dots Between Quality, Engineering, and Regulation to Increase Innovation and Improve Operational Efficiency

Dassault Systemes

Medical device companies often face responsibilities associated with developing, producing, and distributing products that improve quality of life.

Connecting the Dots Between Quality, Engineering, and Regulation to Increase Innovation and Improve Operational Efficiency

In 1923, SCHNEEBERGER laid the foundations for global linear motion technology.

Mini-X Catalogue