your partner in medical and

                                           industrial business

plock consulting EN > services > plock consulting - services - regulatory affairs

regulatory affairs

Concentrate on your main
business and knowledge!

Outsource projects that are not
your base knowledge and
waist your valuably time!

Reducing your internal costs gives
more safety to you on projects!

 

In the regulatory affairs division plock consulting offers the complete range of consulting and support which is needed to develope a medical product for the European and/or American market. In very special questions the plock consulting is working together with different specialized partners so that the customer has the advantage to have only one responsible contact person for the complete project and their regulatory approvals, documents, studies, a.s.o..

pre-market

3.1.1 Regulatory strategy development / project management for start-up
3.1.2 Risk management* by EN14971
3.1.2 Clinical Evaluation* + Clinical study design*
3.1.3 Regulatory submissions
3.1.4 TRF (Test-Report-Form) Design and Evaluation
       for detailed definition and documentation of normative requirements
3.1.5 510(k) and PMA preparation
3.1.6 CE marking, product tests and technical file
3.1.7 MDD Design Dossier* + STED Dossier*
3.1.8 FDA liaison
3.1.9 German Medical Device Directory

* all documents according actual directives, normative standards and MEDDEV / GHTF guidelines

post-market

3.2.1 Establishment registration and device listing
3.2.2 Recall coordination and tracking
3.2.3 Complaint handling
3.2.4 Coordination of regulatory agency inspections

reimbursment in medical technology

REIMBURSMENT IN THE GERMAN HEALTH CARE SYSTEM
3.3.1 DRUGS:
3.3.2 MEDICAL PRODUCT (ambulant):    EMB code
3.3.3 MEDICAL PRODUCT (stationary):   DRG code
3.3.4 MEDICAL TECHNICAL AIDS:           HMV code
3.3.5 OTHER MEDICAL PRODUCTS:        no direct imbursment
                                                      --> IGL, IVV

special services

3.4.1 Test-Documentation
3.4.2 Operation Manuals for medical products
3.4.3 Medical Device Consultant by European Regulations
3.4.4 Medical Device Reporting (MDR) & Medical Device Vigilance (MDV) system
3.4.5 Device Labeling Development and Review

european directive and normative standard specialists

We are specialists for the following european directives and normative standards:

3.5.1 EUROPEAN DIRECTIVES

  • - 93/42/EEC:2007
  • - 2007/47/EEC:2007

3.5.2 NORMATIVE STANDARDS
(unsorted and not prooved to be exhaustive)

  • - DIN EN ISO 13485:2010
  • - EN ISO 14971:2009
  • - EN ISO 14155:2011 (new!)
  • - EN 980:2008 --> EN 15223-1:2007/2009 (new!)
  • - EN 1041:1998
  • - EN 556-1:2000 / AC:2006
  • - EN ISO 10993-1:2003 and family
  • - DIN EN ISO 11139-1:2006
  • - ISO 10012-1
  • - EN ISO 11135:2007
  • - EN ISO 11607-1:2006
  • - EN ISO 11607-2:2006
  • - EN 60601-1:2005 3rd Edition
  • - EN 60601-1-2:2007 3rd Edition
  • - EN 60601-1-6:2004
  • - EN 60601-1-8:2004
  • - EN 60601-2-24:1998
  • - EN 62304:2006
  • - EN 62366:2008
  • - ISO 9626:1991 / Amd1:2001
  • - ISO 7864:1993
  • - ISO 11137-2:2006
  • - ISO 11737-1
  • - ISO 11737-2
  • - EN ISO 8536-4:2007
  • - EN ISO 11607-1:2006
  • - EN ISO 11607-2:2006
  • - DIN EN ISO 8537:2008
  • - EN ISO 8536-4:2007
  • - EN 62366:2008
  • - ISO 11608-1:2000
  • - ISO 11608-2:2000
  • - ISO 11608-3:2000
  • - ISO 11608-4:2000
  • - ISO 13926-1:2004
  • - ISO 13926-2:1999
  • - ISO 15223:2007+Amd1:2008
  • - ISTA 2A