We are now accepting preliminary applications and encourage you to express your interest in participating via the link:

More information:
Bojan Varga
E-mail: bojan.varga@siq.si
Tel.: +386 1 7448 108

The post Advance Your Expertise in Medical Device Compliance and Safety appeared first on SIQ.

Join our community of satisfied customers to stay abreast of the latest requirements, enhance your ability to interpret standards, share best practices, and engage in practical case studies.

FIND OUT MORE and enrol in our courses today! Unlock your savings with our exclusive coupon for SIQ Training: Benefit from a 20% discount on the registration fee using the coupon code SIQLAB24. Act now, as this special offer is valid only from April 1 to June 30, 2024.

Continued employee training is the cornerstone of sustained company excellence.

More information:
Bojan Varga
E-mail: bojan.varga@siq.si
Tel.: +386 1 7448 108

The post Explore our Comprehensive Training Programs Tailored for Laboratories and Inspection Bodies appeared first on SIQ.

Discover our comprehensive training programs, focusing on medical device regulations and related standards. Explore the diverse topics available in the realm of MEDICAL DEVICES and secure your spot today. Take advantage of our special registration offer by using the coupon code SIQMED24, granting you a 10% discount on the registration fee. Hurry, as this exclusive voucher is valid from November 8, 2023, to January 20, 2024.

More information:
Bojan Varga
E-mail: bojan.varga@siq.si
Tel.: +386 1 7448 108

The post Unlock Expertise: Enroll in Our International Online Medical Device Compliance Training for 2024 appeared first on SIQ.

We have extended our international online training programmes with qualified lecturers from the expert field: MEDICAL DEVICES

Join our satisfied customers and:

• keep in touch with the latest requirements and market expectations,
• learn to interpret the requirements,
• exchange good practices and
• work on international case studies.

FIND OUT MORE and apply now to our autumn courses.

Your Coupon for SIQ Trainings:

Use code SIQ23 when registering. Your discount is EUR 50. Valid October 1–December 31, 2023.

The continual education of employees is the added value that keeps a company in good shape in the long run.

More information:
Bojan Varga
E-mail: bojan.varga@siq.si
Tel.: +386 1 7448 108

The post SIQ trainings for the global market – knowledge for trust appeared first on SIQ.

Figure 1.1.

The MDR introduces stricter and more comprehensive requirements for demonstrating the conformity of medical devices. The entire testing and certification procedure is lengthy and can take up to two years, which many manufacturers do not expect. The first steps towards starting the certification procedure, ranging from our first contact with the customer to the confirmation of the offer and the planning of the assessment and audit, are shown in Figure 1.1.

How is the certification procedure conducted?

The organisation submits the technical documentation to the notified body. The latter carries out a brief review, i.e., a preliminary review of the documentation, which involves verifying the adequacy of the documentation structure and determining whether all of the required documents have been included. After confirming the adequacy and completeness of the documentation, the certification procedure can finally be initiated. The first part of the procedure is the assessment of the technical documentation and the clinical evaluation of the device. SIQ involves a range of qualified professionals, including clinical specialists and specialists with specific skills (in software, biocompatibility, sterilisation, etc.), where necessary. Once the assessment of the technical documentation and the clinical evaluation has been completed and the documentation is in compliance with the MDR, the certification procedure continues according to the chosen conformity assessment procedure (See Figure 1.2). 

Most often, manufacturers decide on a conformity assessment procedure set out in Annex IX or Part A of Annex XI, which involves an audit of the established quality management system. In such cases, the certification procedure continues with a certification audit, which may be combined with an audit according to the ISO 13485:2016 standard.

Figure 1.2.

It should be noted that in the entire certification procedure, it is the assessment of the technical documentation and the clinical evaluation (part one of the assessment) that takes the longest, in some cases lasting up to one or two years.

Once all non-compliances have been eliminated by the organisation and all requirements have been met, the notified body issues a certificate (EU) that enables medical device manufacturers to enter the EU market. In the case of conformity assessment according to Annex IX or Part A of Annex XI, the notified body carries out surveillance audits of the certified quality management system once a year, followed by a re-certification audit every fifth year. During the surveillance and re-certification audits, the auditors also review the manufacturer’s reports on post-market follow-up on devices and possible complications, which are called vigilance cases. The notified body carries out an unannounced audit at least once every five years (except in the case of a Class III medical device, where the audit is carried out at least once every two years) to verify how the certificate holder is maintaining and updating its quality management system. Although the overall certification procedure in accordance with the MDR is a completely new procedure, it may be partially adapted if the organisation is already a holder of a valid EC certificate in accordance with the MDD – in the case of an
audit according to Annex IX or Part A of Annex XI, a combined MDD and MDR audit is carried out.

Find out more about the procedure.

The post Procedure for Certification of Medical Devices in Accordance with the Regulation (EU) 2017/745 on Medical Devices (MDR) appeared first on SIQ.

The comprehensive range of services we offer includes testing of the safety and electromagnetic compatibility (EMC) of products, cybersecurity testing, testing according to different harmonised standards, personnel training, interpretation of standards, legislation and certification procedures, as well as management system certification according to different standards (ISO 13485, ISO 9001, ISO 14001, etc.)and certification according to relevant legislation. With these services, we support manufacturers in entering the Slovenian market as well as European and global markets.

The experience we have with the certification of medical devices under the current legislation concerning medical devices (Medical Device Directive 93/42/EEC) shows that manufacturers of medical devices who have a good knowledge of legislative requirements, harmonised standards and guidance documents usually complete the medical device certification procedure faster.

It is therefore recommended that manufacturers first undergo training to familiarise themselves with the requirements of the Regulation (EU) 2017/745 on medical devices (MDR), harmonised standards and the European guidance documents of the Medical Device Coordination Group (MDCG). Information on such training courses, which are available in Slovenian, English, Serbian and Croatian, can be found on the SIQ website under Training – Program – Medical Devices.

In the development phase of a medical device, the manufacturer must involve various experts with specific skills, such as clinical specialists – doctors who, by examining existing scientific literature, establish a scientific medical basis for the development of the device. During the development planning phase, the manufacturer must carry out the first risk assessment involving personnel with technical and medical knowledge. At this stage, the manufacturer must also review the general safety and performance requirements (MDR, Annex I) to identify the requirements relevant to the device and production. This enables the manufacturer to determine which tests and verifications will have to be carried out and which experts will need to be involved – for example, experts in sterilisation, biocompatibility, or electrical safety and electromagnetic compatibility testing. Testing according to the EN 60601 series of standards and other relevant standards can be carried out in our safety and electromagnetic compatibility laboratories. The range of accredited services and other services provided by SIQ laboratories is published on the SIQ website (www.siq.si/en/) under Our Services – Product Testing and Certification – About Us.

If the manufacturer performs the first testing at the device development stage, any defects will come to light early and can be corrected during the development phase. This saves time and ensures that the device can enter the market sooner.

Experience has shown that medical device manufacturers who are more aware of regulatory requirements, harmonised standards and guidance documents complete the certification procedure for their medical device faster.

Find out more about medical device certification and testing.

The post Complete Solutions for Medical Devices appeared first on SIQ.

As a professional, independent and impartial institution, SIQ enables manufacturers of medical devices to place safe medical devices on the market, in conformity with the relevant European legislation.
In addition to providing services for the automotive industry, the certification of medical devices is one of our strategic activities.

In March this year, we became a designated notified body in accordance with the new Medical Device Regulation.

Read more in the latest issue of SIQ Report:

• SIQ Ljubljana Becomes a Notified Body in accordance with the Medical Device Regulation
• Among Twenty-Eight in the World
• Complete Solutions for Medical Devices
• Procedure for Certification of Medical Devices in Accordance with the Regulation (EU) 2017/745 on Medical Devices (MDR)
• Quality Management System according to the MDR
• Technical Documentation according to MDR Requirements
• Post-Market Surveillance
• Certification of Distributors and Importers in Accordance with Article 16 of the MDR
• Medical Device Training
• We hosted a Delegation from Azerbaijan

SIQ Report 82 (pdf)

The post Complete solutions for Medical Devices in Accordance with the Medical Device Regulation appeared first on SIQ.

In this industry, the requirements of a high level of quality and, above all, safety have always been crucial. Slovenia has very successful players in the automotive industry, whose final products contain more and more “made in Slovenia” parts every year.

Many companies enter this industry through a wide supply network. Some do not even produce parts that would be installed in a car, but design or manufacture tools used by other participants in the automotive industry or participate in it primarily through services.

At SIQ, we offer a comprehensive range of training for the automotive industry. We provide the knowledge that employees in the automotive industry need to be able to ensure a high level of quality and safety. Employees must know and understand the requirements of IATF 16949:2016, methods and tools for mastering the quality management system in the automotive industry, such as APQP, PPAP, MSA, FMEA, VDA, and specific customer requirements. Every year, we recognize the need for new skills and offer new courses, such as the IMDS workshop – the international database of materials and the Selection and evaluation of suppliers in the automotive industry.

At an expert meeting in the field of the automotive industry, which took place in February, Dušan Zorc, MSc, a licensed IATF 16949:2016 lecturer and lead management system auditor, summed up his thinking and said that one of the key requirements of the IATF 16949 standard was that management must provide staff who understand their role and have the appropriate competencies. The organization must therefore ensure the competence of the staff on the basis of appropriate education and training. If necessary, action must be taken to obtain the necessary competences.

Find out more about our TRAINING PROGRAM in the automotive industry.

The post Training in the automotive industry appeared first on SIQ.

Join our satisfied customers to:

• keep in touch with the latest requirements and market expectations,
• get knowledge of how to put the requirements into practice,
• exchange good practices, and
• work on international case studies.

FIND OUT MORE and register now for our autumn courses.

More information

MEDICAL DEVICES:
Tatjana Coko
E-mail: tatjana.coko@siq.si
Tel.: +386 1 5609 718

AUTOMOTIVE INDUSTRY:
Tanja Bencek
E-mail: tanja.bencek@siq.si
Tel.: +386 1 5609 894

The post SIQ training programmes for the global market appeared first on SIQ.