ISO 13485 is the internationally recognized standard for Quality Management Systems in Medical Devices; is intended for use by any organization involved in the design, development, production, installation and technical assistance of medical devices or related services.

The ISO 13485:2016 specifies the requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Peercode had developed and implemented it’s quality management system in order to make sure that all possible risks towards patient safety are identified, analyzed and mitigated. Our decision to work towards the ISO 13485:2016 accreditation demonstrates our commitment to providing high-quality and consistent products and services to our clients, while taking this route we have also prepared ourselves for the new Medical Device Regulation (MDR).

The ISO 13485:2016 certification is the assurance that we need in order to work according to the latest standards and regulations, also so that we can assure you as our partner that we have robust, clearly defined procedures in place such as:

• Risk Management
• Post Market Surveillance
• Vigilance
• Corrective and Preventive actions
• Traceability
• Storage
• Supplier selection and evaluation

We are ready for the future with:

• A team consisting of highly motivated, skilled and experienced colleagues
• A company which has more than 20 years of experience
• ISO 13485:2016 certified processes
• ISO27001 certified processes
• Long term relationships with experienced and certified partners (e.g. Degens Regulatory Advice, StaroDub, CloudVPS)
• Development and registration with Farmatec of more than 7 Class 1 Medical Device software products
• Long term working relationship with amongst others: Erasmus MC, Radboud UMC, AMC, Catharina Hospital, Pfizer, Boehringer-Ingelheim, Sanofi USA, Sanofi Genzyme Europe, Merck and 20 Dutch Safety Regions

Please do not hesitate to contact us in case you want to discuss opportunities to develop and launch web services and apps in the Medical Domain that make an impact, comply with regulations (such as MDR) and deliver value to your organization.