The healthcare system is changing at an exponential rate. Rapid technological advancements are creating new possibilities for improving health care, but at the same time this is also creating new challenges.
The expansion of digitalization in health care has put the spotlight on cybersecurity. While the need for information control has always been present, the pace and breadth of digitalization has increased dramatically. Healthcare providers of all sizes need to intensify their efforts in this area.
Key areas: Cybersecurity, NIS directives, GDPR, data integrity
At the same time there are efforts by the EU commission to ensure higher safety and performance of medical devices which reach the market. These are being enforced by the new Medical Device Regulation 2017/745 and In Vitro Diagnostic Regulation 2017/746. Both of which greatly affect the heathcare system and healthcare providers.
Key areas: MDR, IVDR, SOSFS 2008:1.
VALIDATION, VERIFICATION & QUALIFICATION
Validation, verification and qualification are time-consuming, difficult, and completely necessary for organizations operating in complex environments such as health care.
Our specialty knowledge in computerized systems, combined with many years of validation experience in strictly regulated operations (GxP, GAMP 5, ISO 13485, TR 80002-2:2017, etc.) enable us to help you establish cost-effective and high-quality validation strategies that meet your organization’s specific needs.
We possess broad and comprehensive experience of qualification, validation, and verification in all life science areas (pharmaceuticals, medical devices, veterinary medicine, and cosmetics).
We can support you from a pre-project phase (requirements specification) through to the life cycle management phase.
Areas where we can provide support include:
- Integration and validation of computerized systems
- Cloud solutions, or software as a service (Saas)
- Laboratory (IVD) equipment and medical devices
- Clean Rooms
IT SECURITY AND DATA INTEGRITY
Increased regulatory focus on data integrity is affecting all areas of life science, especially the healthcare system. Systems that generate data are subject to intensive review. Electronic and paper-based data need be consistent in meeting standards and regulations throughout their entire lifecycle.
Healthcare providers need to make sure they can meet established requirements and continually monitor them to minimize the risk of becoming noncompliant. The issue is complex and affects many areas of the organization.
PlantVision can help you manage comprehensive data integrity projects or offer specialized services that reinforce your organization wherever needed. Some examples:
We provide support to ensure you gain a comprehensive understanding of the regulations, directives and standards which affect you as a healthcare provider. We can also help you to close any gaps in order to achieve compliance in a way that meets the needs of your organization.
The following areas are examples where our support can be of value in helping you to comply with the new regulations (MDR and IVDR) and directives (SOSFS 2008:1).
- Healthcare providers as manufacturers of medical devices
- Identification and traceability (UDI, Implant cards)
- Healthcare providers as economic operators
- – Distributor role
- – Cases where changes to products might place the legal obligations of manufacturers on healthcare providers
- Reprocessing of single use medical devices
- Custom-devices in health care
Our Compliance Partner program is a flexible solution that gives you access to a long-term quality partner and a variety of services. The framework can be adapted to meet your specific business needs. With Compliance Partner, you get access to our consultants’ collective expertise in a flexible and dynamic way.
Some examples where we can support you as a Compliance Partner…
- Action plans
- Quality management systems and procedures
- Technical documentation
- Risk assessments
- Validations, Verifications & Qualifications
- Product safety and testing
- Specific needs…
Find out more about our Compliance Partner program »