How do you find risks and manage them. Knowing where to look helps speed up your compliance process. 

quality and regulatory – medical grade plastics
It’s all about reducing risk; but do you know where the risks are? How do you install ISO13485? 

Materials used in healthcare applications need to be ‘well-characterised’ and have ‘no-changes’ through the product life cycle. Changes can be intentional changes (change in process or ingredients) or un-intentional (contamination).

Regulatory requirements for plastics are complex good beyond ‘food contact’. You need to have a good understanding of the regulations and potential risks to define a testing strategy.

Quality Management Systems (QMS) such as ISO13485-2016 are focused on risk management but knowing where the risks are in your process can be challenging.

What we offer:
– Practical training on ISO13485 and regulatory requirements such as USP Class 6 and ISO10993
– Implementation of ISO13485 into your plastics manufacturing processes.
– Risk assessment of your existing QMS including on-site audit and preparation for certification.
– Support in supplier selection and raw material sourcing.

Experience:
– Led process to implement ISO13485 in plastics manufacturing sites in Europe, Asia, and USA. Including Management Review, auditing, writing, review and editing SOP.
– Regulatory task-force member – MedPharmplast Europe. Stake-holder position papers eg implementation of MDR.
– Presenter on regulatory, leachables / extractables conferences / workshops eg PDA (Parenteral Drug Association), IPAC-RS (International Pharmaceutical Aerosol Consortium of Regulation & Science), FDA CDRH Workshop.
– Contributor to review of regulatory documents eg revision of USP661.1, position paper titanium dioxide.