Success in the health tech field requires functional operational models that are compliant with regulation. Building a quality management system is an important requirement. Quality and regulatory work is broad and versatile: from us you can get turnkey quality management projects or coaching according to your needs.
Clinipower team has expertise for example from the following regulations and standards:
- MDR, IVDR, MDD, FDA, MDSAP, GMP
- ISO 13485, ISO 9001, ISO 14971, ISO 14155,
IEC 62304, IEC 62366, IEC 82304, HL7
Outsourced quality manager
A competent quality manager effortlessly to your team
Get a professional quality manager easily and cost-effectively as a part of your team through our service. The outsourced quality manager works together with organization management to ensure quality and regulatory compliance. By outsourcing quality manager’s job, you can focus on other core business aspects.
The quality manager handles your organization’s quality affairs comprehensively, including quality management system, risk management, regulatory plan for products, management reviews, and personnel training. The quality manager is your representative for authorities and can offer support for example post-market surveillance and incident reports.
PRRC-service
Person Responsible for Regulatory Compliance as a service
Medical device manufacturers and authorised representatives need to have a Person Responsible for Regulatory Compliance (PRRC) in their service. The role of PRRC can be outsourced to an external person in some cases.
We offer you a PRRC who fulfills the regulatory requirements and is permanently and continuously at your disposal. Our PRRC-service consists of two parts: checking the regulatory compliance of your organization and the PRRC-function itself. The PRRC-service can be combined to our outsourced quality manager service.
Quality management system ISO 13485
Build a functioning quality management system with us
A quality management system (QMS) is the most important requirement for manufacturers of CE-marked health tech products or other operators of the supply chain. By building the QMS according to standard ISO 13485, you can demonstrate conformity with regulatory and customer requirements.
Organizational and process development is closely connected to building a QMS. With our ISO 13485 -project model the QMS can be built both for large organizations and startups.
Risk management ISO 14971
Put a spotlight on safety throughout product life cycle
Medical device risk management is closely connected to ensuring safety of patients and other stakeholder groups. Risk management is a significant part of medical device life cycle. ISO 14971 -standard includes identifying hazards and related hazardous situations, risk analysis, and planning and execution of risk mitigations.
We help implement ISO 14971 risk management into practice and as a part of quality management system.
Audits
Develop your organization’s practices through audits
Audits are systematical and objective evaluations of organizational practices: they aim to ensure that the practices are in accordance with regulation, and recognize needed actions for development. Different types of audits are internal, external, and supplier audits.
Quality advisors of Clinipower have broad experience from medical device and quality management system audits: we offer you an independent and fair auditor. We also provide training and support in preparing for audits.
CE-mark and certification
Place your product successfully on market
Medical device development needs to consider various aspects before the product can be placed on market. We will walk all the way with you and make sure that your product can be CE-marked and certified.
We can support you for example in defining the intended purpose and classification of your product, creating documentation, and certification processes.
Clinical evaluation services
Clinical evaluation as part of medical device life cycle
Clinical evaluation ensures the safety and performance of a medical device. Clinical evaluation is mandatory for devices in all risk classes. In some cases, a clinical investigation is also required to demonstrate conformity. Clinical evaluation continues throughout device life cycle, also after placing on market.
We can assist for example with clinical evaluation plan and report, preparation of clinical testing and collection of post-market data according to your needs.
Read more
How to Build a QMS System for Medical Devices?
Here is the English translation: How to Build a QMS System for Medical Devices? A QMS (Quality Management System) is…
What are the most common challenges in auditing a notified body?
Notified body auditing is an essential process in the health technology field, where a third party evaluates a company’s quality system and documentation for compliance with MDR requirements. The most common challenges relate to documentation management, deficiencies in risk management, and inadequate staff preparation for audit situations. Notified body auditing is a systematic evaluation in which an authorized third-party organization examines a medical device manufacturer’s operational compliance with requirements. The primary purpose of auditing is to ensure that the company complies with the EU Medical Device Regulation (MDR 2017/745) and is capable of safely producing medical devices. Auditing is a central part of the CE marking approval process. Without successful auditing, a company cannot obtain the necessary certificate that authorizes the placing of products on the market in the European region. Health technology auditing focuses particularly on quality system functionality, risk management processes, and product documentation comprehensiveness. Meeting MDR requirements requires […]
Why health technology product development fails – 4 most common pitfalls
Health technology product development is a complex process where even a single wrong step can lead to significant delays, cost increases, or in the worst case, complete project failure. While the industry’s opportunities are enormous, health technology product development contains specific pitfalls that surprise too many companies. Let’s examine the five most common mistakes and methods to avoid them. One of the most serious errors in health technology product development is underestimating user needs. Too often, development teams focus on technical features while forgetting the everyday reality of actual users, such as nurses, doctors, or patients. This leads to products that may function technically flawlessly but do not integrate smoothly into the usage environment. Neglecting usability testing is particularly risky in health technology, as usage errors can compromise patient safety. The IEC 62366 standard requires systematic usability design and testing, but […]
Our experts
Kimmo Vauhkonen
Senior advisor, Quality and Regulatory
Raimo Asikainen
Senior Advisor, Quality
