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PaMed Consulting Karol Pawelec is a Poland-based medical device regulatory consulting provider, focused on support around the EN ISO 13485:2016 medical device quality management system and the EU MDR 2017/745 regulation. According to the website, founder Karol Pawelec spent 6 years at TÜV Rheinland Polska working as a medical device auditor/expert, and established the consulting company in 2022.
The capabilities presented on the website are more in the nature of professional services than SaaS software. Its main services include organizational process analysis, preparation and implementation of ISO 13485 QMS documentation, standards training, internal audits, and employee training. For MDR, it can assist with preparing Annex II technical documentation and Annex III post-market surveillance documentation, and provides compliance role support such as EUDAMED registration, PRRC, management representative, and EU authorized representative. It also offers internal audits, supplier/subcontractor audits, and freelance audit services for certification bodies.
The website does not disclose packages, quotes, billing methods, contract terms, or free trial information, so it is not possible to assess pricing transparency or the procurement threshold. It is more likely to use project-based, consulting-based, or scope-based pricing for audits/training, but this is not stated directly in the text and cannot be confirmed.
The advantage is that its service scope covers common key compliance milestones for medical device companies entering the EU market: ISO 13485, MDR technical documentation, PMS, PRRC, EU authorized representative, and audit preparation. The consultant’s background is also relevant to certification and audit experience. The downside is that, viewed as a SaaS/enterprise software category, it does not demonstrate an online platform, third-party integrations, permission-based collaboration, APIs, deployment options, or data security and compliance capabilities. It also lacks customer cases, pricing, and service SLA information.
It is suitable for medical device manufacturers, especially companies that need to establish or maintain an ISO 13485 system, prepare MDR technical documentation, conduct internal/supplier audits, or, for non-EU manufacturers, need an EU authorized representative. It is not suitable for teams looking for QMS software, an electronic document management system, or an automated compliance platform.
The website does not provide information on access from China, so actual availability needs to be tested. Payment methods are not disclosed. For Chinese companies exporting medical devices to the EU, it could be considered as a candidate external compliance consultant. Alternatives include local medical device regulatory consulting firms, EU authorized representative providers, ISO 13485 consulting companies, or in-house teams with RA/QA capabilities.
⚠ This review is compiled from public sources and does not constitute a purchase recommendation. Verify all facts on the vendor's official site. Verify on pamed-consulting.eu official site.
pamed-consulting.eu is an Poland Legal & Tax provider. TG4G tracks its product information, an overall rating of 6.0/10, and a China-accessibility score of Workable. Click "Visit Official Site" to reach pamed-consulting.eu directly.