White Papers

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?

Your Flexible Friend

Rhenus Contract Logistics

Willem Boersbroek, Rhenus Advanced Services general manager, speaks to about his company's success, which he puts down to a close focus on high-quality administration and a flexible attitude towards the supply chain.

Your Flexible Friend

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In April 2014, the FDA released draft guidance documents for premarket approval, Balancing Premarket and Post-market Data Collection for Devices Subject to Premarket Approval (PMA) and Expedited Access for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

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

MIM – Meeting the Critical Needs of Medical Products

Indo-MIM

Metal injection moulding (MIM) is an emerging manufacturing technology worldwide for small, complex, precise and net shape metal parts.

MIM – Meeting the Critical Needs of Medical Products

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

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

Challenging Perspectives on an Established Wound Healing Technology

Vancive Medical Technologies

The BeneHold family of hydrocolloid wound dressings leverages Vancive's unique and propriety next generation adhesive formulations.

Challenging Perspectives on an Established Wound Healing Technology

Anatomy of an Ethylene Oxide Sterilisation Process

STERIS Isomedix Services

There are many advantages to understanding an ethylene oxide (EO) sterilisation process when considering the different options.

Anatomy of an Ethylene Oxide Sterilisation Process

New Thin Absorbent Skin Adhesive

Vancive Medical Technologies

A new thin absorbent skin adhesive (TASA) has been developed which has similar properties to acrylic adhesive but with the ability to absorb wound exudates.

New Thin Absorbent Skin Adhesive

Converter Benefit Programme: Access Innovative Products and Technology

Vancive Medical Technologies

The Vancive Medical Technologies Converter Benefit Programme offers access to a diverse range of specialized products for the medical device market.

Converter Benefit Programme: Access Innovative Products and Technology

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

Products Commonly Treated with Irradiation

STERIS Isomedix Services

Irradiation is an attractive method for the sterilisation of medical devices and pharmaceuticals.

Products Commonly Treated with Irradiation

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

Why Medical Microelectronics Development Partners Needs Particulate and Microbial Controlled Clean Rooms

Valtronic

Microelectronics technology is increasingly ubiquitous, even within the human body, as medical researchers develop new approaches to monitoring and treating a growing array of illnesses and injuries.

Why Medical Microelectronics Development Partners Needs Particulate and Microbial Controlled Clean Rooms