Kickstart your Medical Device project by:

• Defining clear Product Requirements

• Defining User Requirements

• Developing a robust Design Plan

• Assessing the competitive landscape

• Assessing project feasibility

Initial and ongoing Risk Assessment activities, in compliance with ISO 14971.

• Biological Risk Assessments

• Review and critically assess all available data

• Construct a detailed Biological Evaluation Plan

Develop a preclinical strategy to verify Device performance.

• Identify critical endpoints, develop robust assays and focus your data

• Build confidence in performance and shorten the time to market with a robust and focused preclinical dataset

• Generate powerful preclinical proof of concept data to aid your fund-raising activities and for publication

Medical Device Manufacturing.

• Contract Manufacturing Organisation selection

• Raw materials risk assessment and biological evaluation

• Sterilisation methods and validation process

• Device Release Tests and Specifications

• Manufacturing risk assessments such as Failure Mode Effects Analysis (FMEA)

• Technical transfer of processes and know-how

For Medical Devices requiring terminal Sterilisation:

• The selection of sterilisation methods

• ISO 11737; Microbiological Methods

• ISO 11137; Sterilisation of healthcare products - Radiation

• Bacterial Endotoxin testing; LAL methods (Ph. Eur. 2.6.14)

• Monocyte Activation Test (Ph. Eur. 2.6.30)

ISO 10993 compliant biocompatibility packages.

• Identify the right CRO’s

• Define your study plans

• Monitoring ongoing studies

• Collate and interpret reports

Individual studies or entire Biological Evaluation plans.

Experienced in a range of in vitro and in vivo testing strategies :

• Genotoxicity (ISO 10993-3; In vivo comet test and Bacterial Ames test)  

• Hemocompatibility (ISO 10993-4; interactions with human blood)  

• Cytotoxicity (ISO 10993-5; L929 Cells – Extract Method)  

• Sensitisation (ISO 10993-10; Guinea Pig Maximisation test)  

• Intracutaneous Reactivity (ISO 10993-10; Intradermal reactivity in the rabbit)  

• Systemic Toxicity (ISO 10993-11; Systemic Toxicity)  

• Pyrogenicity (USP41; Pyrogen test in the Rabbit)  

• Endotoxin testing: Monocyte Activation Test (Pharm. Eur. 2.6.30) & Bacterial Endotoxin testing; LAL methods (Ph. Eur. 2.6.14)

• Chemical Characterisation (ISO 10993-18; Leachables and Extractables)

• Toxicological Risk Assessment (ISO 10993-17: Toxicological risk assessment of medical device constituents  

• Sterilisation validation (ISO 11737; Methods and ISO 11137; Sterilisation) 

Committed to ensuring that proper provision has been made for the welfare of animals used in animal tests to assess the biocompatibility of materials used in medical devices (ISO 10993-2).

Device supply for clinical trial or commercial sale.

• Risk assessing manufacturing non-compliances

• Supplier change control risk assessment

• Investigation of Out of Specification test results