Medical Device QA
Key2Compliance® has extensive experience in helping companies of all sizes in the medical device industry with efficient and time-saving quality work in medical device quality assurance.
We can create processes and quality management systems that ensures the quality of your business, no more worries when the next audit appears.
Key2Compliance® supports you with:
- Crew for Quality Manager, QA and PRRC
- Long-term support to your QA/RA staff, based on your needs
- Create, implement and update QMS
- Implement IT-support like Focalcube
- Perform GAP analyzes of your QMS (MDR, ISO 13485, ISO9001, ISO 14001, QSR, etc.)
- Internal audits, supplier audits and mock inspections
- Support at Notified Body audits
- Management review
- Supplier evaluations
- Quality objectives and Process evaluations
Always ready for inspection!
In the development of medical device products and company strategy, an effective Quality Management System (QMS) is the key to long-term success. An effective QMS will make you more ready for the challenges ahead, you will have systems to catch future issues before they become problems and you will be able to plan for necessary changes well in advance. Investing in an effective QMS increases the value of your company and reduces stress for you and your employees. You will always be ready for an inspection and you can welcome the unannounced auditor with a smile.
Key2Compliance® offers a wide range of QMS services. For start-ups we can, together with you, build your QMS from scratch. For more mature companies we can help you with GAP analysis, internal audits, non-conformities, increase of effectiveness or give you a QA/RA refreshment.
Our medical quality assurance consultants have extensive experience in helping medical device companies with a large range of different services. We can be your:
- Quality manager
- PRRC, Person Responsible for Regulatory Compliance
- or just support you with a specific task
All of our services are based on your needs.
Quality Management System (QMS)
All companies at the Medical Device and In-vitro Diagnostics markets are regulated to have a QMS. The international standard ISO 13485:2016 is a good baseline but each market has their own requirements for a QMS.
EU: The QMS requirements are regulated in MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation)
USA: The QMS requirements are regulated in QSR (Quality System Regulation)
MDSAP: Medical Device Single Audit Program, is a union of QMS requirements for USA, Canada, Brazil, Australia and Japan
Key2Compliance® supports you to find the QMS requirements on the markets of your choice.
Worldwide: ISO 13485
ISO 13485:2016 is an international standard serving as a baseline for QMS all over the world.
You can get a certification regarding ISO 13485:2016 from a Notified Body or a certification company. A certification is quality stamp for your company proving that you are fulfilling the standard. A certification increases the value of your company, you can show it on you homepage, to customers and economical partners.
Key2Compliance® supports you to get ready for a certification and also to keep it.
EU: Article 10 MDR/IVDR
In Europe all companies at the Medical Device and In-vitro Diagnostics market are regulated to have a QMS that fulfill MDR/IVDR Article 10, regardless of risk class. MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation).
Key2Compliance® supports you to get create an effective QMS for your type of products and your company size.
USA: Quality System Regulation (QSR)
In USA all companies in the Medical Device industry are regulated to fulfill 21CFR820. On February 22, 2022, the Food and Drug Administration (FDA) published a proposed rule to amend the current QSR regulation to harmonize with ISO 13485: 2016. The intent of the proposed rule is to align FDA’s regulatory framework with that used by other global regulatory authorities, promote consistency in the regulation of medical devices, and provide timelier introduction of safe, effective, high-quality devices to market. The proposition has not yet been effective.
Key2Compliance® supports you to create or update your QMS to fulfill the requirements on the USA market.
MDSAP: Medical Device Single Audit Program, is a union of QMS requirements for USA, Canada, Brazil, Australia and Japan.
Key2Compliance® supports you to create or update your QMS to fulfill the requirements of MDSAP
QMS pays off in the long run
- Increases internal efficiency, you do not have to reinvent the wheel
- Enables structured work and maintains improvements
- Creates trust in customers, suppliers and employees, which in turn improves profitability
- Is a visible proof that the company works in a structured way with quality issues
- Knowledge is not linked to specific individuals and therefore always maintained within the company
- Established information flows reduce the risk of extra work and that important tasks are missed
- Identifies problems quickly and decisions can be made on well-founded information
Is your medical device software MDR ready?
Recording from webinar Dec 16th, 2021 with Stina Gustavsson:
Contact us if you want support with your software MDR compliance.
Medical Device software life cycle processes - IEC 62304 an overview
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