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Quality and Regulatory

Vernacare International Ltd.’s Quality Management System has been assessed and approved as applicable to the design, development, manufacture, and sterilization of a number of product types1. Sites specialising in the design, development, manufacture, or sterilization of products are certified to the relevant ISO standard2 and operate to a Quality Management System which is in Compliance with the relevant regulations3.

Vernacare International Ltd. sites are regularly audited and certified against the relevant ISO standards2 by external auditing institutions. Contact us to request a certificate.

Vernacare International Ltd. has a portfolio of products including CE-marked medical devices that have also been registered for sale in many key international markets. 

References

  1. Product types include but are not limited to: Medical Devices, Veterinary Medical Devices, Machinery, PPE, Cosmetics, Biocides, and General products (approved activities dependent on manufacturing site). 
  2. ISO standards include but are not limited to: 
    Medical Devices / Veterinary Medical Devices – ISO 13485:2016;  
    Cosmetics – ISO 22716:2007; 
    General – ISO 9001:2015. 
  3. Regulations include but are not limited to:  
    Medical Devices – EU Directive 93/42/EEC (MDD); EU Regulation 2017/745 (MDR); UK MDR 2002; US 21 CFR Part 820; Canada SOP/98-282; Australia Therapeutic Goods Regulations 2002. 
    Cosmetics – EU and UK CPR 1223/2009; US 21 CFR Part 700 and 701; Canada C.R.C, c. 869; Australia Therapeutic Goods Act 1989; Australia Therapeutic Goods (Excluded Goods) Determination 2018. 
    General – EU GSPR 2023/998; UK GSPR 2005; US 16 CFR Chapter II; Canada CCPSA 2010; Australia Competition and Consumer Act 2010.